Trial Outcomes & Findings for A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors (NCT NCT02880371)

Last Updated: 2022-06-16

Results Overview

DLT: adverse event (AE) or abnormal laboratory value not clearly attributable to an extraneous cause, such as disease progression, intercurrent illness, or concomitant medications occurring during 21 days of Cycle 1, met 1 of the criteria A) nonhematologic AEs: recurring grade 2 pneumonitis, grade 3 events (irAE, QTcF prolongation, rash; other grade 3/4 except alopecia, nausea, diarrhea, vomiting, tumor flare, pseudoprogression, endocrinopathy); B) hematology AEs/laboratory abnormalities: grade 4 events except lymphopenia, neutropenia, electrolyte imbalances or abnormalities, grade 3 thrombocytopenia, febrile neutropenia, grade 4 AST/ALT elevation, grade 3 AST/ALT elevation lasting \>7 days, associated with bilirubin levels\>=2\*ULN or international normalized ratio \>1.5, grade 3 bilirubin elevation \>=3, CK elevation \>=grade 3 lasting, increase in creatinine \>=1.5\*baseline value, dose delay (dose interruption for \>14 days) or other (inability to receive at least 67% of ARRY-382 doses).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Cycle 1 (up to 21 days)

Results posted on

2022-06-16

Participant Flow

This study had 2 phases: Phase 1B and 2. Originally, Phase 1b of the study had Part A and B. Part A was dose escalation in participants with selected advanced solid tumors. Part B was expansion in melanoma participants. Part C was a part of Phase 2, in participants with non-small cell lung cancer (NSCLC).

There was an amendment in protocol, which removed originally designed Part B and C, due to low enrolment. Post-implementation of this amendment 2, Part B and C were replaced with 3 cohorts in Phase 2. Study then had Part A (Phase 1b), and 3 cohorts in Phase 2. Cohorts of Phase 2 were as follows: 1) PD-1/PD-L1 inhibitor-refractory cohort, 2) pancreatic ductal adenocarcinoma cohort and 3) platinum-resistant ovarian cancer cohort.

Participant milestones

Participant milestones
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 milligrams (mg) orally, once daily (QD) in combination with pembrolizumab at a dose of 2 milligram per kilogram (mg/kg) intravenously (IV) every 3 weeks (Q3W) in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort Participants who progressed on a programmed cell death receptor 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) inhibitor-containing regimen as their most recent prior line of therapy and were new to prior colony-stimulating factor 1 receptor (CSF-1R) or colony-stimulating factor 1(CSF-1) inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort Participants with PDA who had at least 1 prior line of therapy and were new to prior checkpoint inhibitor (CPI) therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b STARTED	6	7	7	1	0	0	0	0
Phase 1b Treated	6	6	7	1	0	0	0	0
Phase 1b COMPLETED	0	0	1	0	0	0	0	0
Phase 1b NOT COMPLETED	6	7	6	1	0	0	0	0
Phase 2 STARTED	0	0	0	0	2	20	28	11
Phase 2 Treated	0	0	0	0	2	19	27	11
Phase 2 COMPLETED	0	0	0	0	0	0	0	0
Phase 2 NOT COMPLETED	0	0	0	0	2	20	28	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 milligrams (mg) orally, once daily (QD) in combination with pembrolizumab at a dose of 2 milligram per kilogram (mg/kg) intravenously (IV) every 3 weeks (Q3W) in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort Participants who progressed on a programmed cell death receptor 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) inhibitor-containing regimen as their most recent prior line of therapy and were new to prior colony-stimulating factor 1 receptor (CSF-1R) or colony-stimulating factor 1(CSF-1) inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort Participants with PDA who had at least 1 prior line of therapy and were new to prior checkpoint inhibitor (CPI) therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b Lost to Follow-up	1	0	0	0	0	0	0	0
Phase 1b Participants terminated by Sponsor	1	0	0	0	0	0	0	0
Phase 1b Withdrawal by Subject	0	0	1	0	0	0	0	0
Phase 1b Death	4	6	5	1	0	0	0	0
Phase 1b Enrolled but not Treated	0	1	0	0	0	0	0	0
Phase 2 Enrolled but not Treated	0	0	0	0	0	1	1	0
Phase 2 Other	0	0	0	0	0	1	2	1
Phase 2 Participants terminated by Sponsor	0	0	0	0	1	6	1	5
Phase 2 Death	0	0	0	0	1	10	20	5
Phase 2 Lost to Follow-up	0	0	0	0	0	0	3	0
Phase 2 Withdrawal by Subject	0	0	0	0	0	1	1	0
Phase 2 End of Study page not completed by error	0	0	0	0	0	1	0	0

Baseline Characteristics

A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=1 Participants Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=2 Participants Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Total n=79 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 12.4 • n=5 Participants	52.2 years STANDARD_DEVIATION 16.0 • n=7 Participants	54.7 years STANDARD_DEVIATION 12.9 • n=5 Participants	68.0 years STANDARD_DEVIATION NA • n=4 Participants	47.0 years STANDARD_DEVIATION 0.0 • n=21 Participants	63.1 years STANDARD_DEVIATION 12.0 • n=8 Participants	65.0 years STANDARD_DEVIATION 9.6 • n=8 Participants	59.3 years STANDARD_DEVIATION 13.1 • n=24 Participants	61.6 years STANDARD_DEVIATION 12.2 • n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	12 Participants n=8 Participants	12 Participants n=8 Participants	11 Participants n=24 Participants	44 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=8 Participants	15 Participants n=8 Participants	0 Participants n=24 Participants	35 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	18 Participants n=8 Participants	23 Participants n=8 Participants	10 Participants n=24 Participants	72 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	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	3 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	5 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	15 Participants n=8 Participants	23 Participants n=8 Participants	9 Participants n=24 Participants	68 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants

PRIMARY outcome

Timeframe: Cycle 1 (up to 21 days)

Population: Dose-determining set (DDS) included all participants in Phase 1b who received at least 67% of the planned cumulative dose of ARRY-382 during Cycle 1 or discontinued the treatment because of DLT.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A: Number of Participants With Dose-Limiting Toxicities (DLT)	0 Participants	1 Participants	2 Participants	—	—	—

PRIMARY outcome

Timeframe: From day of first dose to 30 days after last dose (maximum up to 13.5 months)

Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 millimeter (mm). PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=19 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=27 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=11 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 2 Cohorts: Objective Response Rate (ORR)	0.0 percentage of participants Interval 0.0 to 17.6	3.7 percentage of participants Interval 0.1 to 19.0	0.0 percentage of participants Interval 0.0 to 28.5	—	—	—

SECONDARY outcome

Timeframe: From day of first dose to 30 days after last dose (maximum up to 34.7 months)

Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator review of radiographic disease assessments per RECIST v1.1. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. The analysis was based on confirmed responses for which CR or PR must be confirmed by repeat disease assessment studies performed no less than 4 weeks after the criteria for response were first met to qualify as CR or PR, respectively.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A: Objective Response Rate (ORR)	16.7 percentage of participants Interval 0.4 to 64.1	16.7 percentage of participants Interval 0.0 to 64.1	0.0 percentage of participants Interval 0.0 to 41.0	—	—	—

SECONDARY outcome

Timeframe: From date of first documented CR or PR up to disease progression or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. This outcome measure was evaluated in participants who achieved an objective response. "Overall Number of participants Analyzed" =0, signifies participants did not had documented CR or PR for respective reporting arms.

DOR was defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression, or death due to any cause after achieving a response. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \< 10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. DOR was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=1 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=1 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=1 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Duration of Response (DOR)	29.2 months Upper and lower limit of confidence interval (CI) not reached due to less number of participants with events.	3.1 months Upper and lower limit of CI not reached due to less number of participants with events.	—	—	2.4 months Upper and lower limit of CI not reached due to less number of participants with events.	—

SECONDARY outcome

Timeframe: From day of first dose until disease progression or death due to any cause or till last tumor assessment date (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

PFS was defined as the time from the date of first dose of study drug to the earliest date of disease progression per RECIST v1.1, or death due to any cause, whichever occurs first. If a participant did not have a PFS event at the time of the analysis cut-off or at the start of any new anticancer therapy, PFS was censored at the date of last adequate tumor assessment. PD = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>= 5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Progression-Free Survival (PFS)	4.7 months Interval 1.4 to 33.1	2.3 months Interval 1.3 to 5.7	1.4 months Interval 0.5 to 2.6	1.6 months Interval 1.3 to 4.4	1.4 months Interval 0.9 to 2.8	2.1 months Interval 1.2 to 4.1

SECONDARY outcome

Timeframe: From day of first dose till death due to any cause or date of last contact (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

OS was defined as the time from the start of treatment to the date of death due to any cause. If a death was not observed by the date of the analysis cut-off, OS was censored at the date of last contact. OS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Overall Survival (OS)	14.7 months Interval 5.2 to Upper limit of CI not reached due to less number of participants with events.	7.4 months Interval 2.1 to 14.1	6.5 months Interval 1.0 to Upper limit of CI not reached due to less number of participants with events.	12.4 months Interval 3.6 to Upper limit of CI not reached due to less number of participants with events.	2.2 months Interval 1.5 to 4.9	NA months Interval 5.3 to Median and upper limit of CI not reached due to less number of participants with events.

SECONDARY outcome

Timeframe: From day of first dose till up to end of study treatment (for Phase 1b: maximum up to 33.7 months, for Phase 2: maximum up to 12.5 months)

Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

irRR was defined as the percentage of participants who achieved immune-related best overall response (irBOR) of immune-related CR (irCR) or immune-related PR (irPR), as determined by the investigator per immune related response criteria (irRC). irBOR was the best response using irRC recorded from the start of study treatment until the end of treatment. irCR was the disappearance of all target lesions, irPR was a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Percentage of Participants With Immune-Related Response Rate (irRR)	16.7 percentage of participants Interval 0.4 to 64.1	16.7 percentage of participants Interval 0.4 to 64.1	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 17.6	3.7 percentage of participants Interval 0.1 to 19.0	0.0 percentage of participants Interval 0.0 to 28.5

SECONDARY outcome

Timeframe: From the start of treatment to the time of first documented progression, or death (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

irPFS was defined as the time from the start of treatment to the time of first documented progression per irRC, or death due to any cause. irRC criteria for progression for 1) Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%); 2) New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. For the analysis of irPFS, Kaplan-Meier method was used.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Immune-Related Progression-Free Survival (irPFS)	3.0 months Interval 1.4 to 16.1	2.5 months Interval 1.4 to 7.1	1.3 months Interval 0.5 to 1.5	1.5 months Interval 1.3 to 4.3	1.3 months Interval 0.9 to 2.7	2.5 months Interval 1.2 to Upper limit of CI not reached due to less number of participants with events.

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment discontinuation (before 13.5 months)

Population: FAS included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. This outcome measure was planned in prOVCA cohort. Here "Number Analyzed" signifies number of participants evaluable for specified rows.

Tumor markers were measured for tumor type from serum samples obtained from participants in Phase 2. Mean change from baseline was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=11 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 1 Day 1	578.6 microgram per milliliter Standard Deviation 626.3302643	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 1 Day 8	803.3181818 microgram per milliliter Standard Deviation 808.9155788	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 1 Day 15	1279.833333 microgram per milliliter Standard Deviation 1298.144638	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 2 Day 1	1485.6 microgram per milliliter Standard Deviation 1368.310653	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 3 Day 1	1558.4 microgram per milliliter Standard Deviation 1502.22728	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 4 Day 1	1980 microgram per milliliter Standard Deviation NA Since only 1 evaluable participant, standard deviation could not be calculated.	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 5 Day 1	778 microgram per milliliter Standard Deviation NA Since only 1 evaluable participant, standard deviation could not be calculated.	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 6 Day 1	1730 microgram per milliliter Standard Deviation NA Since only 1 evaluable participant, standard deviation could not be calculated.	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Cycle 7 Day 1	2080 microgram per milliliter Standard Deviation NA Since only 1 evaluable participant, standard deviation could not be calculated.	—	—	—	—	—
Phase 2 prOVCA: Change From Baseline in Tumor Markers at Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, Day 8, 15 of Cycle 1 and Treatment Discontinuation Treatment discontinuation	1743.833333 microgram per milliliter Standard Deviation 1817.18193	—	—	—	—	—

SECONDARY outcome

Timeframe: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	6 Participants	6 Participants	6 Participants	19 Participants	27 Participants	10 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	3 Participants	1 Participants	3 Participants	8 Participants	15 Participants	5 Participants

SECONDARY outcome

Timeframe: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Abnormalities: Albumin (hypoalbuminemia),Alkaline phosphatase (ALP increased), Alanine aminotransferase (ALT increased), Aspartate aminotransferase (AST increased),Total bilirubin (TBL increased), Creatinine (increased), Corrected calcium (hypocalcemia/hypercalcemia), Creatine kinase (CK increased), Glucose (hypoglycemia/hyperglycemia), Amylase (increased), Lipase (increased) ,Phosphate (hypophosphatemia), Magnesium (hypomagnesemia/hypermagnesemia), Potassium (hypokalemia/hyperkalemia), Sodium (hyponatremia/hypernatremia). Participants with all grades and grade 3/4 abnormalities were reported. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Calcium (mmol/L), Hyper: All Grades	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Aspartate Aminotransferase (U/L), Hyper: All Grades	5 Participants	6 Participants	6 Participants	17 Participants	23 Participants	11 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Aspartate Aminotransferase (U/L), Hyper: Grade 3/4	1 Participants	2 Participants	2 Participants	4 Participants	5 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Bilirubin (micromoles per liter [umol/L]), Hyper: All Grades	1 Participants	0 Participants	1 Participants	3 Participants	7 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Bilirubin (umol/L), Hyper: Grade 3/4	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Calcium (mmol/L), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Creatine Kinase (U/L), Hyper: All Grades	5 Participants	5 Participants	5 Participants	16 Participants	20 Participants	7 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Creatine Kinase (U/L), Hyper: Grade 3/4	0 Participants	2 Participants	1 Participants	3 Participants	2 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Creatinine (umol/L), Hyper: All Grades	2 Participants	2 Participants	1 Participants	7 Participants	6 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Creatinine (umol/L), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Glucose (mmol/L), Hypo: All Grades	0 Participants	1 Participants	0 Participants	3 Participants	1 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Glucose (mmol/L), Hypo: Grade 3/4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Glucose (mmol/L), Hyper: All Grades	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Glucose (mmol/L), Hyper: Grade 3/4	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Potassium (mmol/L), Hypo: All Grades	1 Participants	2 Participants	3 Participants	7 Participants	6 Participants	4 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Potassium (mmol/L), Hyper: All Grades	0 Participants	0 Participants	0 Participants	1 Participants	4 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Potassium (mmol/L), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Lipase (U/L), Hyper: All Grades	5 Participants	4 Participants	3 Participants	8 Participants	2 Participants	5 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Lipase (U/L), Hyper: Grade 3/4	2 Participants	2 Participants	0 Participants	7 Participants	0 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Magnesium (mmol/L), Hypo: All Grades	0 Participants	1 Participants	0 Participants	5 Participants	4 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Magnesium (mmol/L), Hypo: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Magnesium (mmol/L), Hyper: All Grades	2 Participants	1 Participants	2 Participants	3 Participants	5 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Magnesium (mmol/L), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Phosphate (mmol/L), Hypo: All Grades	1 Participants	3 Participants	0 Participants	6 Participants	7 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Phosphate (mmol/L), Hypo: Grade 3/4	1 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Sodium (mmol/L), Hypo: All Grades	3 Participants	2 Participants	3 Participants	8 Participants	13 Participants	6 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Albumin (grams per liter [g/L]), Hypo: All Grades	4 Participants	2 Participants	4 Participants	5 Participants	10 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Albumin (g/L), Hypo: Grade 3/4	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Alkaline Phosphatase (units per liter [U/L]), Hyper: All Grades	5 Participants	3 Participants	4 Participants	11 Participants	17 Participants	6 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Alkaline Phosphatase (U/L), Hyper: Grade 3/4	1 Participants	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Alanine Aminotransferase (U/L), Hyper: All Grades	2 Participants	3 Participants	4 Participants	8 Participants	12 Participants	7 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Alanine Aminotransferase (U/L), Hyper: Grade 3/4	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Amylase (U/L), Hyper: All Grades	3 Participants	4 Participants	2 Participants	11 Participants	7 Participants	7 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Amylase (U/L), Hyper: Grade 3/4	2 Participants	0 Participants	0 Participants	3 Participants	1 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Calcium (millimoles per liter [mmol/L]), Hypo: All Grades	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Calcium (mmol/L), Hypo: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Potassium (mmol/L), Hypo: Grade 3/4	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Sodium (mmol/L), Hypo: Grade 3/4	0 Participants	0 Participants	1 Participants	0 Participants	5 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Sodium (mmol/L), Hyper: All Grades	3 Participants	0 Participants	0 Participants	4 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Serum Chemistry Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) Grade 4.03 Sodium (mmol/L), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Hematology abnormalities: Hemoglobin (anemia/hemoglobin increased), Platelets (count decreased), Leukocytes (count decreased/increased), Neutrophils (count decreased), Lymphocytes (count increased/decreased). Coagulation abnormalities: International Normalized Ratio (INR increased), Partial thromboplastin time(PTT)/Activated partial thromboplastin Time (aPTT, time prolonged). Abnormalities were graded by CTCAE grade 4.03 as Grade 1= mild; Grade 2 = moderate; Grade 3/Grade 4 = severe/life-threatening. Participants with all grades and grade 3/4 abnormalities were reported.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Hemoglobin (g/L), Hypo: All Grades	3 Participants	4 Participants	5 Participants	12 Participants	9 Participants	7 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Hemoglobin (g/L), Hypo: Grade 3/4	1 Participants	0 Participants	1 Participants	4 Participants	2 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Hemoglobin (g/L), Hyper: All Grades	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Hemoglobin (g/L), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Lymphocytes (10^9/L), Hypo: All Grades	2 Participants	1 Participants	3 Participants	11 Participants	11 Participants	5 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Lymphocytes (10^9/L), Hypo: Grade 3/4	2 Participants	1 Participants	2 Participants	5 Participants	1 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Lymphocytes (10^9/L), Hyper: All Grades	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Lymphocytes (10^9/L), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Neutrophils (10^9/L), Hypo: All Grades	1 Participants	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Neutrophils (10^9/L), Hypo: Grade 3/4	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Platelets (10^9/L), Hypo: All Grades	1 Participants	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Platelets (10^9/L), Hypo: Grade 3/4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Leukocytes (10^9/L), Hypo: All Grades	2 Participants	1 Participants	3 Participants	4 Participants	2 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Leukocytes (10^9/L), Hypo: Grade 3/4	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Leukocytes (10^9/L), Hyper: All Grades	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Leukocytes (10^9/L), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Activated Partial Thromboplastin Time (sec), Hyper: All Grades	2 Participants	2 Participants	2 Participants	6 Participants	7 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Activated Partial Thromboplastin Time (sec), Hyper: Grade 3/4	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Prothrombin Intl. Normalized Ratio (INR Units), Hyper: All Grades	1 Participants	3 Participants	2 Participants	9 Participants	15 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring or Worsening Hematology and Coagulation Laboratory Abnormalities Graded by CTCAE Grade 4.03 Prothrombin Intl. Normalized Ratio (INR Units), Hyper: Grade 3/4	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here "Number Analyzed" signifies number of participants evaluable for specified rows.

Liver function parameters/abnormalities: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): \>3\* upper limit of normal (ULN), \>5\*ULN, \>8\*ULN, \>10\*ULN, \>20\*ULN; Bilirubin \>1.5\*ULN, \>2\*ULN; Alkaline phosphatase (ALP) \>2\*ULN, \>3\*ULN.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Alanine Aminotransferase: >3*ULN	0 Participants	2 Participants	2 Participants	3 Participants	2 Participants	4 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Alanine Aminotransferase: >5*ULN	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Alanine Aminotransferase: >8*ULN	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Alanine Aminotransferase: >10*ULN	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Alanine Aminotransferase: >20*ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Alkaline Phosphatase: >2*ULN	1 Participants	3 Participants	2 Participants	5 Participants	12 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Alkaline Phosphatase: >3*ULN	1 Participants	0 Participants	1 Participants	4 Participants	9 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Aspartate Aminotransferase: >3*ULN	2 Participants	3 Participants	4 Participants	7 Participants	13 Participants	5 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Aspartate Aminotransferase: >5*ULN	1 Participants	2 Participants	2 Participants	4 Participants	5 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Aspartate Aminotransferase: >8*ULN	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Aspartate Aminotransferase: >10*ULN	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Aspartate Aminotransferase: >20*ULN	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Bilirubin: >1.5*ULN	0 Participants	0 Participants	1 Participants	1 Participants	5 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests Bilirubin: >2*ULN	0 Participants	0 Participants	1 Participants	1 Participants	4 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST: AT >3*ULN	2 Participants	3 Participants	4 Participants	7 Participants	13 Participants	5 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST: AT >5*ULN	1 Participants	2 Participants	2 Participants	4 Participants	5 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST: AT >8*ULN	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST: AT >10*ULN	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST: AT >20*ULN	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST and Total Bilirubin >2ULN: AT >3ULN	0 Participants	0 Participants	1 Participants	1 Participants	4 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST and Total Bilirubin >2ULN: AT >5ULN	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST and Total Bilirubin >2ULN: AT >10ULN	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALP >3ULN and Total Bilirubin >2ULN	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Abnormal Liver Function Tests ALT or AST >3ULN and ALP <2ULN and Total Bilirubin >2*ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Thyroid panel laboratory parameters/abnormalities: thyrotropin, free triiodothyronine (T3), free thyroxine (T4). Shift in thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: Low (at baseline) to Low (at post baseline)	0 Participants	1 Participants	1 Participants	3 Participants	3 Participants	4 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: Low (at baseline) to Normal (at post baseline)	1 Participants	0 Participants	0 Participants	3 Participants	3 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: Low (at baseline) to High (at post baseline)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: Low (at baseline) to Missing (at post baseline)	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: Normal (at baseline) to Low (at post baseline)	1 Participants	0 Participants	2 Participants	0 Participants	4 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: Normal (at baseline) to Normal (at post baseline)	3 Participants	2 Participants	3 Participants	12 Participants	12 Participants	7 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: Normal (at baseline) to High (at post baseline)	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: Normal (at baseline) to Missing (at post baseline)	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: High (at baseline) to Low (at post baseline)	—	0 Participants	—	—	—	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: High (at baseline) to Normal (at post baseline)	—	1 Participants	—	—	—	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: High (at baseline) to High (at post baseline)	—	0 Participants	—	—	—	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Triiodothyronine, Free: High (at baseline) to Missing (at post baseline)	—	0 Participants	—	—	—	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: Low (at baseline) to Low (at post baseline)	—	—	—	0 Participants	2 Participants	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: Low (at baseline) to Normal (at post baseline)	—	—	—	1 Participants	0 Participants	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: Low (at baseline) to High (at post baseline)	—	—	—	0 Participants	0 Participants	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: Low (at baseline) to Missing (at post baseline)	—	—	—	0 Participants	1 Participants	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: Normal (at baseline) to Low (at post baseline)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: Normal (at baseline) to Normal (at post baseline)	3 Participants	2 Participants	6 Participants	12 Participants	18 Participants	8 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: Normal (at baseline) to High (at post baseline)	1 Participants	3 Participants	0 Participants	3 Participants	0 Participants	2 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: Normal (at baseline) to Missing (at post baseline)	1 Participants	0 Participants	1 Participants	0 Participants	4 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: High (at baseline) to Low (at post baseline)	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: High (at baseline) to Normal (at post baseline)	0 Participants	0 Participants	—	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: High (at baseline) to High (at post baseline)	1 Participants	1 Participants	—	2 Participants	2 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyroxine, Free: High (at baseline) to Missing (at post baseline)	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: Low (at baseline) to Low (at post baseline)	—	0 Participants	—	—	—	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: Low (at baseline) to Normal (at post baseline)	—	1 Participants	—	—	—	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: Low (at baseline) to High (at post baseline)	—	0 Participants	—	—	—	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: Low (at baseline) to Missing (at post baseline)	—	0 Participants	—	—	—	—
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: Normal (at baseline) to Low (at post baseline)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: Normal (at baseline) to Normal (at post baseline)	2 Participants	4 Participants	5 Participants	14 Participants	12 Participants	5 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: Normal (at baseline) to High (at post baseline)	3 Participants	0 Participants	0 Participants	4 Participants	5 Participants	5 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: Normal (at baseline) to Missing (at post baseline)	1 Participants	0 Participants	0 Participants	0 Participants	5 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: High (at baseline) to Low (at post baseline)	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: High (at baseline) to Normal (at post baseline)	—	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: High (at baseline) to High (at post baseline)	—	1 Participants	0 Participants	1 Participants	5 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Shift in Thyroid Panel Severity From Baseline Grade to Post Baseline Grades Thyrotropin: High (at baseline) to Missing (at post baseline)	—	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab.

Urinalysis laboratory parameters/abnormalities: Decimal logarithm of reciprocal of hydrogen ion activity (pH), specific gravity, protein, glucose, ketones, nitrite, blood, leukocyte esterase, microscopy (if urine tested positive for blood or protein). Clinical significance was judged by investigator.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Clinically Significant Urinalysis Finding	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: First dose of study drug up to 30 days after last dose (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months)

Population: Safety set included all participants who received at least 1 dose (partial or full) of ARRY-382 or pembrolizumab. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, body temperature and weight. Low SBP: less than or equal to (\<=)90 millimeter of mercury (mmHg) with decrease from baseline of \>=20 mmHg. High SBP: \>=160 mmHg with increase from baseline of \>=20 mmHg. Low DBP: \<=50 mmHg with decrease from baseline of \>=15 mmHg. High DBP: \>=100 mmHg with increase from baseline of \>=15 mmHg. Low heart rate: \<=50 beats/min with decrease from baseline of \>=15 beats/min. High heart rate: \>=120 beats/min with increase from baseline of \>=15 beats/min. Low temperature: \<=36 degree Celsius (C). High temperature: \>=37.5 degree C. Low Weight: decrease from baseline \>=20%. High weight: increase from baseline \>=10%.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities DBP: High	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities SBP: High	3 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities SBP: Low	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities DBP: Low	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities Heart Rate: High	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities Heart Rate: Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities Temperature: High	1 Participants	0 Participants	1 Participants	1 Participants	3 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities Temperature: Low	4 Participants	1 Participants	2 Participants	3 Participants	5 Participants	1 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities Weight: High	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Phase 1b, Part A and Phase 2 Cohorts: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities Weight: Low	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hour(hr) (±5 min), 2 hours(hrs) (±10 min), 4 hrs (±20 min) and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2

Population: Pharmacokinetic (PK) set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382. Here "Number Analyzed" signifies number of participants evaluated for given time points.

The lower limit of quantitation (LLOQ) for analyte ARRY-382 was 5.00 nanogram per milliliter (ng/mL).

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 1 Day 1 / 1 hr Post ARRY-382 dose	283 nanogram per milliliter Geometric Coefficient of Variation 422	49.7 nanogram per milliliter Geometric Coefficient of Variation 1130	305 nanogram per milliliter Geometric Coefficient of Variation 263	664 nanogram per milliliter Geometric Coefficient of Variation 194	373 nanogram per milliliter Geometric Coefficient of Variation 282	695 nanogram per milliliter Geometric Coefficient of Variation 145
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose	542 nanogram per milliliter Geometric Coefficient of Variation 78.8	497 nanogram per milliliter Geometric Coefficient of Variation 201	827 nanogram per milliliter Geometric Coefficient of Variation 64.2	1060 nanogram per milliliter Geometric Coefficient of Variation 65.8	982 nanogram per milliliter Geometric Coefficient of Variation 101	1160 nanogram per milliliter Geometric Coefficient of Variation 57.2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 1 Day1 / 4 hrs Post ARRY-382 dose	530 nanogram per milliliter Geometric Coefficient of Variation 37.9	845 nanogram per milliliter Geometric Coefficient of Variation 49.0	1130 nanogram per milliliter Geometric Coefficient of Variation 50.0	1010 nanogram per milliliter Geometric Coefficient of Variation 44.7	976 nanogram per milliliter Geometric Coefficient of Variation 72.6	937 nanogram per milliliter Geometric Coefficient of Variation 54.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 1 Day1 / 8 hrs Post ARRY-382 dose	384 nanogram per milliliter Geometric Coefficient of Variation 26.3	566 nanogram per milliliter Geometric Coefficient of Variation 28.8	757 nanogram per milliliter Geometric Coefficient of Variation 46.8	683 nanogram per milliliter Geometric Coefficient of Variation 43.7	662 nanogram per milliliter Geometric Coefficient of Variation 76.7	500 nanogram per milliliter Geometric Coefficient of Variation 52.6
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 1 Day 15 / Pre ARRY-382 dose	616 nanogram per milliliter Geometric Coefficient of Variation 43.0	533 nanogram per milliliter Geometric Coefficient of Variation 34.2	888 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	862 nanogram per milliliter Geometric Coefficient of Variation 57.3	918 nanogram per milliliter Geometric Coefficient of Variation 79.1	485 nanogram per milliliter Geometric Coefficient of Variation 117
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 2 Day 1 / Pre ARRY-382 dose	576 nanogram per milliliter Geometric Coefficient of Variation 59.5	762 nanogram per milliliter Geometric Coefficient of Variation 6.44	1040 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	330 nanogram per milliliter Geometric Coefficient of Variation 2050	1550 nanogram per milliliter Geometric Coefficient of Variation 18.8	438 nanogram per milliliter Geometric Coefficient of Variation 86.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 2 Day 1 / 1 hr Post ARRY-382 dose	1170 nanogram per milliliter Geometric Coefficient of Variation 76.5	1310 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	1430 nanogram per milliliter Geometric Coefficient of Variation 195	1320 nanogram per milliliter Geometric Coefficient of Variation 97.5	2000 nanogram per milliliter Geometric Coefficient of Variation 14.3	1220 nanogram per milliliter Geometric Coefficient of Variation 64.2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose	1530 nanogram per milliliter Geometric Coefficient of Variation 45.2	1600 nanogram per milliliter Geometric Coefficient of Variation 106	2560 nanogram per milliliter Geometric Coefficient of Variation 117	1830 nanogram per milliliter Geometric Coefficient of Variation 92.2	3000 nanogram per milliliter Geometric Coefficient of Variation 9.01	1580 nanogram per milliliter Geometric Coefficient of Variation 79.6
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose	1200 nanogram per milliliter Geometric Coefficient of Variation 57.6	2030 nanogram per milliliter Geometric Coefficient of Variation 35.1	2120 nanogram per milliliter Geometric Coefficient of Variation 126	1630 nanogram per milliliter Geometric Coefficient of Variation 66.6	2900 nanogram per milliliter Geometric Coefficient of Variation 4.73	1450 nanogram per milliliter Geometric Coefficient of Variation 62.7
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose	1100 nanogram per milliliter Geometric Coefficient of Variation 35.7	1680 nanogram per milliliter Geometric Coefficient of Variation 8.22	1440 nanogram per milliliter Geometric Coefficient of Variation 142	1530 nanogram per milliliter Geometric Coefficient of Variation 52.3	2150 nanogram per milliliter Geometric Coefficient of Variation 7.22	973 nanogram per milliliter Geometric Coefficient of Variation 75.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 3 Day 1 / Pre ARRY-382 dose	565 nanogram per milliliter Geometric Coefficient of Variation 39.5	305 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	554 nanogram per milliliter Geometric Coefficient of Variation 70.3	324 nanogram per milliliter Geometric Coefficient of Variation 391	336 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 4 Day 1 / Pre ARRY-382 dose	405 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	—	—	1080 nanogram per milliliter Geometric Coefficient of Variation 119	728 nanogram per milliliter Geometric Coefficient of Variation 85.2	522 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 5 Day 1 / Pre ARRY-382 dose	NA nanogram per milliliter Geometric Coefficient of Variation NA Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.	—	—	92.6 nanogram per milliliter Geometric Coefficient of Variation 13300	1000 nanogram per milliliter Geometric Coefficient of Variation 35.1	76.6 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 6 Day 1 / Pre ARRY-382 dose	—	—	—	798 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	1100 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	518 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 7 Day 1 / Pre ARRY-382 dose	—	—	—	573 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	505 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 8 Day 1 / Pre ARRY-382 dose	—	—	—	424 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 9 Day 1 / Pre ARRY-382 dose	—	—	—	350 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of ARRY-382 Cycle 10 Day 1 / Pre ARRY-382 dose	—	—	—	244 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—

SECONDARY outcome

Timeframe: Pre dose of ARRY-382 (120 minutes prior to administration): on Day 15 of Cycle 1, on Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9 , 10; 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) post dose of ARRY-382 on Day 1 of Cycle 1, 2

Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469099 was reported in this outcome measure. The LLOQ for analyte AR00469099 was 1.00 ng/mL.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 3 Day 1 / Pre ARRY-382 dose	121 nanogram per milliliter Geometric Coefficient of Variation 81.8	31.0 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	123 nanogram per milliliter Geometric Coefficient of Variation 210	70.6 nanogram per milliliter Geometric Coefficient of Variation 243	54.0 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 1 Day 1 / 1 hr Post ARRY-382 dose	10.6 nanogram per milliliter Geometric Coefficient of Variation 750	NA nanogram per milliliter Geometric Coefficient of Variation NA Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.	8.57 nanogram per milliliter Geometric Coefficient of Variation 404	21.0 nanogram per milliliter Geometric Coefficient of Variation 234	7.95 nanogram per milliliter Geometric Coefficient of Variation 493	22.6 nanogram per milliliter Geometric Coefficient of Variation 164
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose	36.3 nanogram per milliliter Geometric Coefficient of Variation 219	19.6 nanogram per milliliter Geometric Coefficient of Variation 495	57.2 nanogram per milliliter Geometric Coefficient of Variation 151	66.2 nanogram per milliliter Geometric Coefficient of Variation 80.5	54.7 nanogram per milliliter Geometric Coefficient of Variation 177	60.8 nanogram per milliliter Geometric Coefficient of Variation 52.9
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 1 Day1 / 4 hrs Post ARRY-382 dose	69.5 nanogram per milliliter Geometric Coefficient of Variation 128	83.6 nanogram per milliliter Geometric Coefficient of Variation 69.2	170 nanogram per milliliter Geometric Coefficient of Variation 72.6	110 nanogram per milliliter Geometric Coefficient of Variation 48.9	113 nanogram per milliliter Geometric Coefficient of Variation 109	89.1 nanogram per milliliter Geometric Coefficient of Variation 39.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 1 Day1 / 8 hrs Post ARRY-382 dose	74.9 nanogram per milliliter Geometric Coefficient of Variation 85.3	96.4 nanogram per milliliter Geometric Coefficient of Variation 62.9	205 nanogram per milliliter Geometric Coefficient of Variation 88.7	119 nanogram per milliliter Geometric Coefficient of Variation 49.5	132 nanogram per milliliter Geometric Coefficient of Variation 101	75.7 nanogram per milliliter Geometric Coefficient of Variation 41.6
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 1 Day 15 / Pre ARRY-382 dose	136 nanogram per milliliter Geometric Coefficient of Variation 30.8	73.7 nanogram per milliliter Geometric Coefficient of Variation 62.1	190 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	210 nanogram per milliliter Geometric Coefficient of Variation 78.8	250 nanogram per milliliter Geometric Coefficient of Variation 172	83.3 nanogram per milliliter Geometric Coefficient of Variation 132
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 2 Day 1 / Pre ARRY-382 dose	136 nanogram per milliliter Geometric Coefficient of Variation 67.7	199 nanogram per milliliter Geometric Coefficient of Variation 82.5	188 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	96.5 nanogram per milliliter Geometric Coefficient of Variation 2860	511 nanogram per milliliter Geometric Coefficient of Variation 189	77.1 nanogram per milliliter Geometric Coefficient of Variation 85.2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 2 Day 1 / 1 hr Post ARRY-382 dose	133 nanogram per milliliter Geometric Coefficient of Variation 72.0	245 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	177 nanogram per milliliter Geometric Coefficient of Variation 94.7	254 nanogram per milliliter Geometric Coefficient of Variation 29.2	475 nanogram per milliliter Geometric Coefficient of Variation 173	102 nanogram per milliliter Geometric Coefficient of Variation 68.2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose	166 nanogram per milliliter Geometric Coefficient of Variation 66.0	166 nanogram per milliliter Geometric Coefficient of Variation 133	241 nanogram per milliliter Geometric Coefficient of Variation 73.8	272 nanogram per milliliter Geometric Coefficient of Variation 36.2	510 nanogram per milliliter Geometric Coefficient of Variation 174	133 nanogram per milliliter Geometric Coefficient of Variation 54.1
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose	177 nanogram per milliliter Geometric Coefficient of Variation 89.6	208 nanogram per milliliter Geometric Coefficient of Variation 129	305 nanogram per milliliter Geometric Coefficient of Variation 62.0	298 nanogram per milliliter Geometric Coefficient of Variation 55.6	544 nanogram per milliliter Geometric Coefficient of Variation 168	157 nanogram per milliliter Geometric Coefficient of Variation 50.7
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose	210 nanogram per milliliter Geometric Coefficient of Variation 57.5	320 nanogram per milliliter Geometric Coefficient of Variation 71.9	313 nanogram per milliliter Geometric Coefficient of Variation 77.8	324 nanogram per milliliter Geometric Coefficient of Variation 44.1	561 nanogram per milliliter Geometric Coefficient of Variation 152	146 nanogram per milliliter Geometric Coefficient of Variation 58.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 4 Day 1 / Pre ARRY-382 dose	79.9 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	—	—	157 nanogram per milliliter Geometric Coefficient of Variation 228	138 nanogram per milliliter Geometric Coefficient of Variation 30.0	70.3 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 5 Day 1 / Pre ARRY-382 dose	NA nanogram per milliliter Geometric Coefficient of Variation NA Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.	—	—	11.5 nanogram per milliliter Geometric Coefficient of Variation 4020	170 nanogram per milliliter Geometric Coefficient of Variation 10.4	7.92 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 6 Day 1 / Pre ARRY-382 dose	—	—	—	86.9 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	141 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	110 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 7 Day 1 / Pre ARRY-382 dose	—	—	—	61.5 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	103 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 8 Day 1 / Pre ARRY-382 dose	—	—	—	42.7 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 9 Day 1 / Pre ARRY-382 dose	—	—	—	30.6 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469099 Cycle 10 Day 1 / Pre ARRY-382 dose	—	—	—	27.0 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—

SECONDARY outcome

Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00469100 was reported in this outcome measure. The LLOQ for analyte AR00469100 was 1.00 ng/mL.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 1 Day 1 / 1 hr Post ARRY-382 dose	19.5 nanogram per milliliter Geometric Coefficient of Variation 667	NA nanogram per milliliter Geometric Coefficient of Variation NA Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.	16.6 nanogram per milliliter Geometric Coefficient of Variation 584	61.0 nanogram per milliliter Geometric Coefficient of Variation 337	21.3 nanogram per milliliter Geometric Coefficient of Variation 553	75.4 nanogram per milliliter Geometric Coefficient of Variation 131
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose	47.1 nanogram per milliliter Geometric Coefficient of Variation 109	43.0 nanogram per milliliter Geometric Coefficient of Variation 468	71.0 nanogram per milliliter Geometric Coefficient of Variation 96.9	114 nanogram per milliliter Geometric Coefficient of Variation 69.1	81.9 nanogram per milliliter Geometric Coefficient of Variation 150	123 nanogram per milliliter Geometric Coefficient of Variation 51.2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 1 Day1 / 4 hrs Post ARRY-382 dose	41.7 nanogram per milliliter Geometric Coefficient of Variation 79.2	82.7 nanogram per milliliter Geometric Coefficient of Variation 55.7	110 nanogram per milliliter Geometric Coefficient of Variation 40.5	102 nanogram per milliliter Geometric Coefficient of Variation 62.0	85.5 nanogram per milliliter Geometric Coefficient of Variation 84.8	101 nanogram per milliliter Geometric Coefficient of Variation 46.8
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 1 Day1 / 8 hrs Post ARRY-382 dose	28.2 nanogram per milliliter Geometric Coefficient of Variation 71.2	53.9 nanogram per milliliter Geometric Coefficient of Variation 42.5	67.7 nanogram per milliliter Geometric Coefficient of Variation 40.5	65.4 nanogram per milliliter Geometric Coefficient of Variation 64.8	56.4 nanogram per milliliter Geometric Coefficient of Variation 83.3	44.0 nanogram per milliliter Geometric Coefficient of Variation 50.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 1 Day 15 / Pre ARRY-382 dose	70.7 nanogram per milliliter Geometric Coefficient of Variation 81.2	69.4 nanogram per milliliter Geometric Coefficient of Variation 24.5	116 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	106 nanogram per milliliter Geometric Coefficient of Variation 94.1	96.0 nanogram per milliliter Geometric Coefficient of Variation 85.3	60.8 nanogram per milliliter Geometric Coefficient of Variation 121
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 2 Day 1 / Pre ARRY-382 dose	60.1 nanogram per milliliter Geometric Coefficient of Variation 103	107 nanogram per milliliter Geometric Coefficient of Variation 45.5	146 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	35.2 nanogram per milliliter Geometric Coefficient of Variation 977	184 nanogram per milliliter Geometric Coefficient of Variation 91.1	57.1 nanogram per milliliter Geometric Coefficient of Variation 99.2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 2 Day 1 / 1 hr Post ARRY-382 dose	105 nanogram per milliliter Geometric Coefficient of Variation 98.3	169 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	138 nanogram per milliliter Geometric Coefficient of Variation 228	116 nanogram per milliliter Geometric Coefficient of Variation 75.2	191 nanogram per milliliter Geometric Coefficient of Variation 92.5	173 nanogram per milliliter Geometric Coefficient of Variation 39.1
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose	138 nanogram per milliliter Geometric Coefficient of Variation 81.9	196 nanogram per milliliter Geometric Coefficient of Variation 81.9	268 nanogram per milliliter Geometric Coefficient of Variation 141	165 nanogram per milliliter Geometric Coefficient of Variation 81.7	265 nanogram per milliliter Geometric Coefficient of Variation 65.5	226 nanogram per milliliter Geometric Coefficient of Variation 66.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose	108 nanogram per milliliter Geometric Coefficient of Variation 108	228 nanogram per milliliter Geometric Coefficient of Variation 39.5	219 nanogram per milliliter Geometric Coefficient of Variation 131	139 nanogram per milliliter Geometric Coefficient of Variation 57.4	264 nanogram per milliliter Geometric Coefficient of Variation 75.1	164 nanogram per milliliter Geometric Coefficient of Variation 67.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose	104 nanogram per milliliter Geometric Coefficient of Variation 75.9	210 nanogram per milliliter Geometric Coefficient of Variation 27.1	161 nanogram per milliliter Geometric Coefficient of Variation 158	124 nanogram per milliliter Geometric Coefficient of Variation 39.5	218 nanogram per milliliter Geometric Coefficient of Variation 74.8	107 nanogram per milliliter Geometric Coefficient of Variation 77.8
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 3 Day 1 / Pre ARRY-382 dose	63.2 nanogram per milliliter Geometric Coefficient of Variation 108	57.3 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	73.2 nanogram per milliliter Geometric Coefficient of Variation 73.5	54.8 nanogram per milliliter Geometric Coefficient of Variation 255	32.7 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 4 Day 1 / Pre ARRY-382 dose	31.1 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	—	—	108 nanogram per milliliter Geometric Coefficient of Variation 109	75.5 nanogram per milliliter Geometric Coefficient of Variation 88.7	67.6 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 5 Day 1 / Pre ARRY-382 dose	NA nanogram per milliliter Geometric Coefficient of Variation NA Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.	—	—	14.0 nanogram per milliliter Geometric Coefficient of Variation 6560	112 nanogram per milliliter Geometric Coefficient of Variation 46.2	11.7 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 6 Day 1 / Pre ARRY-382 dose	—	—	—	110 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	148 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	72.8 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 7 Day 1 / Pre ARRY-382 dose	—	—	—	73.2 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	67.4 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 8 Day 1 / Pre ARRY-382 dose	—	—	—	51.3 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 9 Day 1 / Pre ARRY-382 dose	—	—	—	44.0 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00469100 Cycle 10 Day 1 / Pre ARRY-382 dose	—	—	—	33.8 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—

SECONDARY outcome

Drug ARRY-382 had its three metabolites AR00469099, AR00469100 and AR00470870. Plasma concentration of metabolite AR00470870 was reported in this outcome measure. The LLOQ for analyte AR00470870 was 1.00 ng/mL.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 1 Day 1 / 1 hr Post ARRY-382 dose	14.6 nanogram per milliliter Geometric Coefficient of Variation 835	NA nanogram per milliliter Geometric Coefficient of Variation NA Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.	11.7 nanogram per milliliter Geometric Coefficient of Variation 410	46.9 nanogram per milliliter Geometric Coefficient of Variation 403	12.6 nanogram per milliliter Geometric Coefficient of Variation 1100	71.7 nanogram per milliliter Geometric Coefficient of Variation 125
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 1 Day 1 / 2 hrs Post ARRY-382 dose	49.4 nanogram per milliliter Geometric Coefficient of Variation 193	36.7 nanogram per milliliter Geometric Coefficient of Variation 2940	68.7 nanogram per milliliter Geometric Coefficient of Variation 113	140 nanogram per milliliter Geometric Coefficient of Variation 97.9	74.8 nanogram per milliliter Geometric Coefficient of Variation 277	189 nanogram per milliliter Geometric Coefficient of Variation 59.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 1 Day1 / 4 hrs Post ARRY-382 dose	64.5 nanogram per milliliter Geometric Coefficient of Variation 101	159 nanogram per milliliter Geometric Coefficient of Variation 106	182 nanogram per milliliter Geometric Coefficient of Variation 73.7	191 nanogram per milliliter Geometric Coefficient of Variation 59.9	129 nanogram per milliliter Geometric Coefficient of Variation 116	220 nanogram per milliliter Geometric Coefficient of Variation 46.9
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 1 Day1 / 8 hrs Post ARRY-382 dose	53.7 nanogram per milliliter Geometric Coefficient of Variation 78.4	144 nanogram per milliliter Geometric Coefficient of Variation 71.3	162 nanogram per milliliter Geometric Coefficient of Variation 52.6	150 nanogram per milliliter Geometric Coefficient of Variation 56.8	123 nanogram per milliliter Geometric Coefficient of Variation 90.1	148 nanogram per milliliter Geometric Coefficient of Variation 46.7
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 1 Day 15 / Pre ARRY-382 dose	105 nanogram per milliliter Geometric Coefficient of Variation 86.9	255 nanogram per milliliter Geometric Coefficient of Variation 11.0	231 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	259 nanogram per milliliter Geometric Coefficient of Variation 49.3	307 nanogram per milliliter Geometric Coefficient of Variation 74.0	242 nanogram per milliliter Geometric Coefficient of Variation 33.5
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 2 Day 1 / Pre ARRY-382 dose	99.1 nanogram per milliliter Geometric Coefficient of Variation 80.8	294 nanogram per milliliter Geometric Coefficient of Variation 49.3	216 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	83.4 nanogram per milliliter Geometric Coefficient of Variation 2600	285 nanogram per milliliter Geometric Coefficient of Variation 58.4	224 nanogram per milliliter Geometric Coefficient of Variation 34.1
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 2 Day 1 / 1 hr Post ARRY-382 dose	122 nanogram per milliliter Geometric Coefficient of Variation 63.9	377 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	206 nanogram per milliliter Geometric Coefficient of Variation 68.5	244 nanogram per milliliter Geometric Coefficient of Variation 58.1	279 nanogram per milliliter Geometric Coefficient of Variation 53.8	316 nanogram per milliliter Geometric Coefficient of Variation 26.4
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 2 Day 1 / 2 hrs Post ARRY-382 dose	165 nanogram per milliliter Geometric Coefficient of Variation 49.3	444 nanogram per milliliter Geometric Coefficient of Variation 29.0	283 nanogram per milliliter Geometric Coefficient of Variation 68.8	337 nanogram per milliliter Geometric Coefficient of Variation 70.2	310 nanogram per milliliter Geometric Coefficient of Variation 47.2	462 nanogram per milliliter Geometric Coefficient of Variation 16.9
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 2 Day 1 / 4 hrs Post ARRY-382 dose	149 nanogram per milliliter Geometric Coefficient of Variation 54.4	503 nanogram per milliliter Geometric Coefficient of Variation 26.8	327 nanogram per milliliter Geometric Coefficient of Variation 61.2	320 nanogram per milliliter Geometric Coefficient of Variation 65.9	348 nanogram per milliliter Geometric Coefficient of Variation 40.3	486 nanogram per milliliter Geometric Coefficient of Variation 18.9
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 2 Day 1 / 8 hrs Post ARRY-382 dose	151 nanogram per milliliter Geometric Coefficient of Variation 58.9	460 nanogram per milliliter Geometric Coefficient of Variation 37.6	306 nanogram per milliliter Geometric Coefficient of Variation 47.9	337 nanogram per milliliter Geometric Coefficient of Variation 55.3	345 nanogram per milliliter Geometric Coefficient of Variation 36.1	401 nanogram per milliliter Geometric Coefficient of Variation 19.2
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 3 Day 1 / Pre ARRY-382 dose	118 nanogram per milliliter Geometric Coefficient of Variation 88.7	250 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	156 nanogram per milliliter Geometric Coefficient of Variation 87.0	194 nanogram per milliliter Geometric Coefficient of Variation 65.0	194 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 4 Day 1 / Pre ARRY-382 dose	77.4 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	—	—	161 nanogram per milliliter Geometric Coefficient of Variation 113	263 nanogram per milliliter Geometric Coefficient of Variation 13.5	158 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 5 Day 1 / Pre ARRY-382 dose	NA nanogram per milliliter Geometric Coefficient of Variation NA Since concentration was below quantifiable limit, geometric mean and geometric coefficient of variation could not be calculated.	—	—	16.4 nanogram per milliliter Geometric Coefficient of Variation 10600	268 nanogram per milliliter Geometric Coefficient of Variation 18.2	33.8 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 6 Day 1 / Pre ARRY-382 dose	—	—	—	73.5 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	419 nanogram per milliliter Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	192 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 7 Day 1 / Pre ARRY-382 dose	—	—	—	60.7 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	236 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 8 Day 1 / Pre ARRY-382 dose	—	—	—	62.8 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 9 Day 1 / Pre ARRY-382 dose	—	—	—	73.8 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—
Phase 1b, Part A and Phase 2 Cohorts: Plasma Concentration Versus Time Profile of Metabolite AR00470870 Cycle 10 Day 1 / Pre ARRY-382 dose	—	—	—	90.6 nanogram per milliliter Geometric Coefficient of Variation NA Due to insufficient number of participants with events, geometric coefficient of variation could not be calculated.	—	—

SECONDARY outcome

Timeframe: 0 to 24 hrs after administration of ARRY-382 on Day 1 of Cycle 2

Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

AUCtau was defined as area under the plasma concentration-time curve over the dosing interval, where dosing interval was 24 hours.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=4 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=4 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=3 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=5 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=4 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=5 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) ARRY-382	22800 hour*nanogram per milliliter Geometric Coefficient of Variation 44.2	30600 hour*nanogram per milliliter Geometric Coefficient of Variation 26.6	30800 hour*nanogram per milliliter Geometric Coefficient of Variation 130	32100 hour*nanogram per milliliter Geometric Coefficient of Variation 65.7	47100 hour*nanogram per milliliter Geometric Coefficient of Variation 10.2	20700 hour*nanogram per milliliter Geometric Coefficient of Variation 70.6
Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) AR00469099	4150 hour*nanogram per milliliter Geometric Coefficient of Variation 63.5	4530 hour*nanogram per milliliter Geometric Coefficient of Variation 106	5880 hour*nanogram per milliliter Geometric Coefficient of Variation 78.8	7920 hour*nanogram per milliliter Geometric Coefficient of Variation 18.9	14200 hour*nanogram per milliliter Geometric Coefficient of Variation 123	2840 hour*nanogram per milliliter Geometric Coefficient of Variation 61.8
Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) AR00469100	2170 hour*nanogram per milliliter Geometric Coefficient of Variation 85.9	3860 hour*nanogram per milliliter Geometric Coefficient of Variation 33.9	3510 hour*nanogram per milliliter Geometric Coefficient of Variation 142	2670 hour*nanogram per milliliter Geometric Coefficient of Variation 53.4	5360 hour*nanogram per milliliter Geometric Coefficient of Variation 62.8	2480 hour*nanogram per milliliter Geometric Coefficient of Variation 73.9
Phase 1b, Part A and Phase 2 Cohorts: Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady-State (AUCtau, ss) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) AR00470870	3180 hour*nanogram per milliliter Geometric Coefficient of Variation 59.0	9810 hour*nanogram per milliliter Geometric Coefficient of Variation 29.3	6200 hour*nanogram per milliliter Geometric Coefficient of Variation 45.2	6850 hour*nanogram per milliliter Geometric Coefficient of Variation 61.2	7940 hour*nanogram per milliliter Geometric Coefficient of Variation 36.9	8220 hour*nanogram per milliliter Geometric Coefficient of Variation 20.3

SECONDARY outcome

Timeframe: Pre dose of ARRY-382 (120 minutes prior to administration), 1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2

Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.

Cmax was obtained from plasma concentration time curve. Cmax at single dose was reported at Cycle1 Day 1 and Cmax at steady state was reported at Cycle 2 Day 1.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 ARRY-382	773 nanogram per milliliter Geometric Coefficient of Variation 60.2	995 nanogram per milliliter Geometric Coefficient of Variation 68.9	1330 nanogram per milliliter Geometric Coefficient of Variation 39.6	1240 nanogram per milliliter Geometric Coefficient of Variation 62.1	1290 nanogram per milliliter Geometric Coefficient of Variation 75.6	1260 nanogram per milliliter Geometric Coefficient of Variation 53.9
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 ARRY-382	1560 nanogram per milliliter Geometric Coefficient of Variation 41.3	2260 nanogram per milliliter Geometric Coefficient of Variation 36.6	2560 nanogram per milliliter Geometric Coefficient of Variation 117	2130 nanogram per milliliter Geometric Coefficient of Variation 60.4	2820 nanogram per milliliter Geometric Coefficient of Variation 15.1	1580 nanogram per milliliter Geometric Coefficient of Variation 64.8
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00469099	84.0 nanogram per milliliter Geometric Coefficient of Variation 102	100 nanogram per milliliter Geometric Coefficient of Variation 59.8	219 nanogram per milliliter Geometric Coefficient of Variation 83.8	119 nanogram per milliliter Geometric Coefficient of Variation 50.9	142 nanogram per milliliter Geometric Coefficient of Variation 97.9	95.4 nanogram per milliliter Geometric Coefficient of Variation 43.2
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469099	212 nanogram per milliliter Geometric Coefficient of Variation 57.3	241 nanogram per milliliter Geometric Coefficient of Variation 103	328 nanogram per milliliter Geometric Coefficient of Variation 75.6	328 nanogram per milliliter Geometric Coefficient of Variation 44.0	646 nanogram per milliliter Geometric Coefficient of Variation 111	161 nanogram per milliliter Geometric Coefficient of Variation 50.8
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00469100	61.2 nanogram per milliliter Geometric Coefficient of Variation 78.3	104 nanogram per milliliter Geometric Coefficient of Variation 86.5	122 nanogram per milliliter Geometric Coefficient of Variation 41.7	132 nanogram per milliliter Geometric Coefficient of Variation 70.0	116 nanogram per milliliter Geometric Coefficient of Variation 98.3	138 nanogram per milliliter Geometric Coefficient of Variation 46.5
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469100	138 nanogram per milliliter Geometric Coefficient of Variation 81.6	257 nanogram per milliliter Geometric Coefficient of Variation 36.4	268 nanogram per milliliter Geometric Coefficient of Variation 141	181 nanogram per milliliter Geometric Coefficient of Variation 56.9	279 nanogram per milliliter Geometric Coefficient of Variation 54.9	215 nanogram per milliliter Geometric Coefficient of Variation 52.5
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00470870	70.1 nanogram per milliliter Geometric Coefficient of Variation 95.1	174 nanogram per milliliter Geometric Coefficient of Variation 92.5	196 nanogram per milliliter Geometric Coefficient of Variation 58.5	193 nanogram per milliliter Geometric Coefficient of Variation 60.5	147 nanogram per milliliter Geometric Coefficient of Variation 98.9	231 nanogram per milliliter Geometric Coefficient of Variation 50.8
Phase 1b, Part A and Phase 2 Cohorts: Maximum Observed Plasma Concentration (Cmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00470870	172 nanogram per milliliter Geometric Coefficient of Variation 51.6	534 nanogram per milliliter Geometric Coefficient of Variation 22.0	333 nanogram per milliliter Geometric Coefficient of Variation 60.7	373 nanogram per milliliter Geometric Coefficient of Variation 60.6	363 nanogram per milliliter Geometric Coefficient of Variation 30.9	486 nanogram per milliliter Geometric Coefficient of Variation 18.9

SECONDARY outcome

Timeframe: Pre dose of ARRY-382 (120 minutes prior to administration) on Day 1 of Cycle 2

Measured concentration at the pre-dose at steady-state.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=4 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=4 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=3 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=5 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=4 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=5 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) ARRY-382	576 nanogram per milliliter Geometric Coefficient of Variation 59.5	667 nanogram per milliliter Geometric Coefficient of Variation 27.7	627 nanogram per milliliter Geometric Coefficient of Variation 126	878 nanogram per milliliter Geometric Coefficient of Variation 70.1	1480 nanogram per milliliter Geometric Coefficient of Variation 17.5	438 nanogram per milliliter Geometric Coefficient of Variation 86.5
Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) AR00469099	136 nanogram per milliliter Geometric Coefficient of Variation 67.7	146 nanogram per milliliter Geometric Coefficient of Variation 105	161 nanogram per milliliter Geometric Coefficient of Variation 105	277 nanogram per milliliter Geometric Coefficient of Variation 27.1	557 nanogram per milliliter Geometric Coefficient of Variation 136	77.1 nanogram per milliliter Geometric Coefficient of Variation 85.2
Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) AR00469100	60.1 nanogram per milliliter Geometric Coefficient of Variation 103	96.0 nanogram per milliliter Geometric Coefficient of Variation 43.9	83.6 nanogram per milliliter Geometric Coefficient of Variation 137	82.4 nanogram per milliliter Geometric Coefficient of Variation 57.1	193 nanogram per milliliter Geometric Coefficient of Variation 71.3	57.1 nanogram per milliliter Geometric Coefficient of Variation 99.2
Phase 1b, Part A and Phase 2 Cohorts: Ctrough at Steady State for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) AR00470870	99.1 nanogram per milliliter Geometric Coefficient of Variation 80.8	313 nanogram per milliliter Geometric Coefficient of Variation 41.7	185 nanogram per milliliter Geometric Coefficient of Variation 27.9	232 nanogram per milliliter Geometric Coefficient of Variation 58.5	302 nanogram per milliliter Geometric Coefficient of Variation 48.1	224 nanogram per milliliter Geometric Coefficient of Variation 34.1

SECONDARY outcome

Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.

Tmax was obtained from plasma concentration time curve. Tmax at single dose was reported at Cycle 1 Day 1 and Tmax at steady state was reported at Cycle 2 Day 1.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 ARRY-382	2.00 hours Interval 1.0 to 7.95	4.01 hours Interval 1.25 to 4.05	4.07 hours Interval 0.983 to 8.0	1.97 hours Interval 0.95 to 4.17	2.00 hours Interval 0.967 to 8.0	2.00 hours Interval 1.0 to 4.1
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 ARRY-382	2.00 hours Interval 2.0 to 7.95	4.18 hours Interval 1.85 to 7.48	1.98 hours Interval 1.97 to 2.0	2.00 hours Interval 1.0 to 7.5	3.03 hours Interval 2.0 to 4.08	2.00 hours Interval 1.83 to 4.17
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00469099	7.98 hours Interval 4.0 to 8.02	7.81 hours Interval 3.97 to 8.0	7.95 hours Interval 4.0 to 8.02	5.88 hours Interval 3.98 to 8.0	5.83 hours Interval 1.92 to 8.03	4.17 hours Interval 2.0 to 8.0
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469099	7.94 hours Interval 4.1 to 8.05	7.68 hours Interval 3.85 to 8.0	8.00 hours Interval 4.0 to 8.0	7.50 hours Interval 4.0 to 8.0	5.90 hours Interval 0.0 to 8.0	4.05 hours Interval 2.0 to 7.5
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00469100	2.00 hours Interval 1.0 to 4.07	2.98 hours Interval 1.25 to 4.05	4.07 hours Interval 0.983 to 8.0	2.00 hours Interval 1.0 to 4.17	2.00 hours Interval 0.967 to 8.02	2.00 hours Interval 1.0 to 4.1
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469100	2.00 hours Interval 2.0 to 7.95	3.03 hours Interval 1.85 to 7.48	1.98 hours Interval 1.97 to 2.0	1.98 hours Interval 1.0 to 7.5	3.90 hours Interval 2.0 to 4.03	2.00 hours Interval 0.917 to 3.75
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00470870	3.00 hours Interval 2.0 to 8.02	4.03 hours Interval 1.83 to 8.0	4.07 hours Interval 4.0 to 8.0	4.00 hours Interval 2.0 to 7.58	4.07 hours Interval 1.92 to 8.02	3.80 hours Interval 1.88 to 4.15
Phase 1b, Part A and Phase 2 Cohorts: Time to Reach Maximum Observed Plasma Concentration (Tmax) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00470870	3.00 hours Interval 2.0 to 7.95	4.18 hours Interval 1.85 to 7.48	8.00 hours Interval 4.0 to 8.0	4.03 hours Interval 1.95 to 7.5	5.78 hours Interval 4.0 to 8.0	4.05 hours Interval 3.75 to 4.17

SECONDARY outcome

Timeframe: Pre dose of ARRY-382 (120 minutes prior to administration),1 hrs (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2

Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one post dose blood draw to determine plasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here "Number Analyzed" signifies number of participants evaluated for given time points.

Different MR reported for single dose calculated at Cycle 1 Day 1 were as follows: 1) MRAUClast = ratio of AUClast values of the metabolite compared to parent, corrected for molecular weight, where AUClast was area under the plasma concentration-time curve from zero to the last measurable time point; 2) MRCmax = ratio of Cmax values of the metabolite compared to parent, corrected for molecular weight. Different MR reported for steady state calculated at Cycle 2 Day 1 were as follows: 1) MRAUCtau,ss = ratio of AUCtau,ss values of the metabolite compared to parent, corrected for molecular weight, where AUCtau was area under the plasma concentration-time curve over a dosing interval at steady-state; 2) MRCmax,ss = Ratio of Cmax,ss values of the metabolite compared to parent, corrected for molecular weight.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469099 MRAUCtau,ss	0.177 ratio Geometric Coefficient of Variation 35.6	0.144 ratio Geometric Coefficient of Variation 80.3	0.186 ratio Geometric Coefficient of Variation 84.6	0.240 ratio Geometric Coefficient of Variation 69.0	0.292 ratio Geometric Coefficient of Variation 132	0.134 ratio Geometric Coefficient of Variation 27.5
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469099 MRCmax,ss	0.132 ratio Geometric Coefficient of Variation 20.5	0.103 ratio Geometric Coefficient of Variation 68.2	0.125 ratio Geometric Coefficient of Variation 74.8	0.150 ratio Geometric Coefficient of Variation 89.9	0.222 ratio Geometric Coefficient of Variation 108	0.0991 ratio Geometric Coefficient of Variation 24.0
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00469099 MRAUClast	0.115 ratio Geometric Coefficient of Variation 86.8	0.101 ratio Geometric Coefficient of Variation 47.9	0.151 ratio Geometric Coefficient of Variation 70.9	0.101 ratio Geometric Coefficient of Variation 45.7	0.108 ratio Geometric Coefficient of Variation 63.4	0.0821 ratio Geometric Coefficient of Variation 31.3
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00469099 MRCmax	0.106 ratio Geometric Coefficient of Variation 58.8	0.0979 ratio Geometric Coefficient of Variation 74.9	0.160 ratio Geometric Coefficient of Variation 79.5	0.0929 ratio Geometric Coefficient of Variation 46.5	0.107 ratio Geometric Coefficient of Variation 71.8	0.0734 ratio Geometric Coefficient of Variation 38.3
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00469100 MRAUClast	0.0817 ratio Geometric Coefficient of Variation 40.7	0.101 ratio Geometric Coefficient of Variation 33.4	0.0934 ratio Geometric Coefficient of Variation 31.0	0.104 ratio Geometric Coefficient of Variation 39.3	0.0883 ratio Geometric Coefficient of Variation 41.2	0.108 ratio Geometric Coefficient of Variation 22.9
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00469100 MRCmax	0.0811 ratio Geometric Coefficient of Variation 45.0	0.107 ratio Geometric Coefficient of Variation 35.0	0.0941 ratio Geometric Coefficient of Variation 21.8	0.109 ratio Geometric Coefficient of Variation 47.2	0.0923 ratio Geometric Coefficient of Variation 41.3	0.112 ratio Geometric Coefficient of Variation 29.8
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469100 MRAUCtau,ss	0.0978 ratio Geometric Coefficient of Variation 43.8	0.129 ratio Geometric Coefficient of Variation 27.1	0.117 ratio Geometric Coefficient of Variation 13.1	0.0853 ratio Geometric Coefficient of Variation 13.8	0.117 ratio Geometric Coefficient of Variation 66.4	0.123 ratio Geometric Coefficient of Variation 40.8
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469100 MRCmax,ss	0.0909 ratio Geometric Coefficient of Variation 41.4	0.116 ratio Geometric Coefficient of Variation 29.3	0.108 ratio Geometric Coefficient of Variation 24.5	0.0873 ratio Geometric Coefficient of Variation 19.2	0.101 ratio Geometric Coefficient of Variation 52.8	0.140 ratio Geometric Coefficient of Variation 44.3
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00470870 MRAUClast	0.0946 ratio Geometric Coefficient of Variation 104	0.159 ratio Geometric Coefficient of Variation 42.7	0.127 ratio Geometric Coefficient of Variation 44.9	0.151 ratio Geometric Coefficient of Variation 71.1	0.106 ratio Geometric Coefficient of Variation 64.0	0.176 ratio Geometric Coefficient of Variation 72.4
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 1 Day 1 AR00470870 MRCmax	0.0775 ratio Geometric Coefficient of Variation 119	0.149 ratio Geometric Coefficient of Variation 26.6	0.126 ratio Geometric Coefficient of Variation 30.4	0.133 ratio Geometric Coefficient of Variation 78.0	0.0974 ratio Geometric Coefficient of Variation 51.4	0.156 ratio Geometric Coefficient of Variation 71.6
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00470870 MRAUCtau,ss	0.119 ratio Geometric Coefficient of Variation 80.2	0.273 ratio Geometric Coefficient of Variation 43.1	0.172 ratio Geometric Coefficient of Variation 66.7	0.182 ratio Geometric Coefficient of Variation 69.3	0.144 ratio Geometric Coefficient of Variation 41.1	0.340 ratio Geometric Coefficient of Variation 59.0
Phase 1b, Part A and Phase 2 Cohorts: Metabolite-to-Parent Ratio (MR) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00470870 MRCmax,ss	0.0941 ratio Geometric Coefficient of Variation 84.4	0.201 ratio Geometric Coefficient of Variation 36.1	0.111 ratio Geometric Coefficient of Variation 42.7	0.150 ratio Geometric Coefficient of Variation 66.6	0.110 ratio Geometric Coefficient of Variation 31.3	0.263 ratio Geometric Coefficient of Variation 59.6

SECONDARY outcome

Timeframe: Pre dose of ARRY-382 (120 minutes prior to administration),1 hr (±5 min), 2 hrs (±10 min), 4 hrs (±20 min), and 8 hrs (±30 min) after administration of ARRY-382 on Day 1 of Cycle 1 and 2

Population: PK set included all participants who had received any active study intervention (ARRY-382), with at least one postdose blood draw to determineplasma concentration of ARRY-382 and its metabolites (AR00469099, AR00469100 and AR00470870). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

Accumulation ratio was calculated and reported for Cmax as RCmax and for AUC as RAUC. RCmax = Cmax at steady-state on Day 1 of Cycle 2 divided by Cmax on Day 1 of Cycle 1. RAUC = AUC from zero to 8 hours after drug administration at steady-state on Day 1 of Cycle 2 divided by AUC from zero to 8 hours after drug administration on Day 1 of Cycle 1.

Outcome measures

Outcome measures
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=4 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=4 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=3 Participants Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=6 Participants Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=4 Participants Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=5 Participants Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469100 RAUC	3.49 ratio Geometric Coefficient of Variation 51.7	1.97 ratio Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	3.96 ratio Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	2.64 ratio Geometric Coefficient of Variation 36.3	3.84 ratio Geometric Coefficient of Variation 13.5	1.93 ratio Geometric Coefficient of Variation 23.0
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 ARRY-382 RAUC	3.03 ratio Geometric Coefficient of Variation 47.9	1.92 ratio Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	3.52 ratio Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	2.67 ratio Geometric Coefficient of Variation 36.2	3.41 ratio Geometric Coefficient of Variation 23.6	1.87 ratio Geometric Coefficient of Variation 16.7
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 ARRY-382 RCmax	2.53 ratio Geometric Coefficient of Variation 48.2	2.51 ratio Geometric Coefficient of Variation 95.7	2.28 ratio Geometric Coefficient of Variation 54.2	2.52 ratio Geometric Coefficient of Variation 39.9	2.07 ratio Geometric Coefficient of Variation 53.6	1.62 ratio Geometric Coefficient of Variation 24.7
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469099 RAUC	4.03 ratio Geometric Coefficient of Variation 93.0	4.36 ratio Geometric Coefficient of Variation NA Since only 1 evaluable participant, geometric coefficient of variation could not be calculated.	4.28 ratio Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	4.67 ratio Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	4.95 ratio Geometric Coefficient of Variation 41.8	2.07 ratio Geometric Coefficient of Variation 23.8
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469099 RCmax	3.03 ratio Geometric Coefficient of Variation 53.4	2.54 ratio Geometric Coefficient of Variation 52.0	2.47 ratio Geometric Coefficient of Variation 38.5	3.19 ratio Geometric Coefficient of Variation 36.7	3.56 ratio Geometric Coefficient of Variation 48.4	1.93 ratio Geometric Coefficient of Variation 37.4
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00469100 RCmax	2.67 ratio Geometric Coefficient of Variation 46.1	2.60 ratio Geometric Coefficient of Variation 157	2.50 ratio Geometric Coefficient of Variation 65.1	2.44 ratio Geometric Coefficient of Variation 41.3	2.08 ratio Geometric Coefficient of Variation 49.0	1.76 ratio Geometric Coefficient of Variation 29.5
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00470870 RAUC	3.47 ratio Geometric Coefficient of Variation 94.9	4.48 ratio Geometric Coefficient of Variation NA Since only 1 evaluable participant, geometric coefficient of variation could not be calculated.	2.73 ratio Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	4.01 ratio Geometric Coefficient of Variation NA As planned geometric coefficient of variation would not be calculated and reported if evaluable participants were less than 3.	3.30 ratio Geometric Coefficient of Variation 61.9	2.03 ratio Geometric Coefficient of Variation 23.9
Phase 1b, Part A and Phase 2 Cohorts: Accumulation Ratio (R) for ARRY-382 and Metabolites (AR00469099, AR00469100, and AR00470870) Cycle 2 Day 1 AR00470870 RCmax	2.72 ratio Geometric Coefficient of Variation 54.5	3.59 ratio Geometric Coefficient of Variation 95.3	2.02 ratio Geometric Coefficient of Variation 20.1	2.39 ratio Geometric Coefficient of Variation 48.6	2.03 ratio Geometric Coefficient of Variation 38.7	1.77 ratio Geometric Coefficient of Variation 31.0

Adverse Events

Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab

Serious events: 3 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab

Serious events: 1 serious events

Other events: 6 other events

Deaths: 6 deaths

Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort

Serious events: 8 serious events

Other events: 19 other events

Deaths: 10 deaths

Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort

Serious events: 15 serious events

Other events: 26 other events

Deaths: 20 deaths

Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort

Serious events: 5 serious events

Other events: 10 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 participants at risk Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 participants at risk Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 participants at risk Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=1 participants at risk Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=2 participants at risk Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 participants at risk Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 participants at risk Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 participants at risk Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
General disorders Pyrexia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Pneumonitis	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Cardiac disorders Atrioventricular block	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Peritonitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Cerebrovascular accident	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Rash morbilliform	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Ascites	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Constipation	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Enterocolitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Gastric perforation	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Ileus	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Gastrointestinal haemorrhage	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Haematemesis	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Nausea	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.2% 2/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Pneumonia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Pneumococcal sepsis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Urinary tract infection	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Urosepsis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood bilirubin increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Urine output decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Cerebral thrombosis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Metabolic encephalopathy	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Cardiac disorders Cardiac failure congestive	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Hepatobiliary disorders Hepatitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Injury, poisoning and procedural complications Head injury	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Hypotension	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Psychiatric disorders confusional state	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	100.0% 1/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.

Other adverse events

Other adverse events
Measure	Phase 1b, Part A: 200 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 participants at risk Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 200 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=6 participants at risk Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part A: 400 mg ARRY-382 + 2 mg/kg Pembrolizumab n=7 participants at risk Participants with selected advanced solid tumors received ARRY-382 capsules at a dose of 400 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 1b, Part B: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=1 participants at risk Participants with melanoma received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2, Part C: 300 mg ARRY-382 + 2 mg/kg Pembrolizumab n=2 participants at risk Participants with NSCLC received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 2 mg/kg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: PD-1/PD-L1 Inhibitor-Refractory Cohort n=19 participants at risk Participants who progressed on a PD-1/ PD-L1 inhibitor-containing regimen as their most recent prior line of therapy and were new to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Pancreatic Ductal Adenocarcinoma (PDA) Cohort n=27 participants at risk Participants with PDA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.	Phase 2: Platinum-resistant Ovarian Cancer (prOVCA) Cohort n=11 participants at risk Participants with prOVCA who had at least 1 prior line of therapy and were new to prior CPI therapy and to prior CSF-1R or CSF-1 inhibitors were included in this reporting arm. Participants received ARRY-382 capsules at a dose of 300 mg orally, QD in combination with pembrolizumab at a dose of 200 mg IV Q3W in each 21-day treatment cycle until disease progression, participant refusal, lost to follow-up, unacceptable toxicity, or the study termination by the sponsor and a 30-day safety follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	28.6% 2/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Pruritus	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Nail ridging	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Night sweats	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Dehydration	50.0% 3/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	26.3% 5/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.8% 4/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.2% 2/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Decreased appetite	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	15.8% 3/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 9/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.2% 2/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	28.6% 2/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.8% 4/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Aspartate aminotransferase increased	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	100.0% 6/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	57.1% 4/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	42.1% 8/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 9/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	36.4% 4/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood creatine phosphokinase increased	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 3/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	42.9% 3/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	47.4% 9/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.5% 5/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.2% 2/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Alanine aminotransferase increased	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 3/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	28.6% 2/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	15.8% 3/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.5% 5/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	36.4% 4/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	42.9% 3/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	26.3% 5/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.8% 4/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Lipase increased	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	66.7% 4/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	31.6% 6/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Amylase increased	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 3/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	21.1% 4/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Weight decreased	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	28.6% 2/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	15.8% 3/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Aldolase increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood bilirubin increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood creatinine increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood lactate dehydrogenase increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood pressure increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Electrocardiogram T wave abnormal	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Glomerular filtration rate decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Heart rate increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Lymphocyte count decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Neutrophil count decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Weight increased	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations White blood cell count decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Fatigue	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	42.9% 3/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	52.6% 10/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	59.3% 16/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	27.3% 3/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Pyrexia	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	28.6% 2/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	27.3% 3/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Chills	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Asthenia	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Influenza like illness	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Oedema peripheral	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	15.8% 3/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Pain	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Nausea	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	42.9% 3/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	47.4% 9/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	44.4% 12/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	45.5% 5/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	42.1% 8/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 9/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Dry mouth	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	21.1% 4/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	22.2% 6/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	27.3% 3/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Constipation	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	28.6% 2/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	25.9% 7/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	27.3% 3/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Ascites	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Gastric varices	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Gastrooesophageal reflux disease	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Pancreatitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Stomatitis	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	57.1% 4/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	26.3% 5/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 9/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	28.6% 2/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.8% 4/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	21.1% 4/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.8% 4/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	36.4% 4/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Pneumonitis	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Bronchitis	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Cystitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Lung infection	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Oral candidiasis	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Pneumonia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Malaise	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Urinary tract infection	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	33.3% 2/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Muscular weakness	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Pathological fracture	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Headache	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	27.3% 3/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Dizziness	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Dementia	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Syncope	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Psychiatric disorders Insomnia	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Psychiatric disorders Depression	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Psychiatric disorders Anxiety	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Eye disorders Dry eye	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Eye disorders Lacrimation increased	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Eye disorders Periorbital oedema	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Eye disorders Vision blurred	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Hot flush	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Embolism	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Hypertension	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Hypotension	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Endocrine disorders Hypothyroidism	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Endocrine disorders Thyroiditis acute	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	28.6% 2/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Dysuria	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Haematuria	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Proteinuria	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Ear and labyrinth disorders Hypoacusis	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Reproductive system and breast disorders Prostatic obstruction	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.3% 1/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	16.7% 1/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	42.1% 8/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	14.8% 4/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.2% 2/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Colitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Anal fistula	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Anal incontinence	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Eructation	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Haematemesis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Haematochezia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Proctalgia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Rectal tenesmus	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Non-cardiac chest pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Gait disturbance	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Performance status decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Catheter site pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Chest discomfort	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Chest pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Early satiety	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Face oedema	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Localised oedema	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Temperature intolerance	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
General disorders Thirst	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations International normalised ratio increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Platelet count decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Ammonia increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood magnesium decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood sodium decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Creatinine renal clearance decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Prothrombin time prolonged	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Troponin increased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Investigations Urine output decreased	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.2% 2/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Fluid retention	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Dysgeusia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.2% 2/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Somnolence	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Akathisia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Dysgraphia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Hypogeusia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Memory impairment	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Myoclonus	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Restless legs syndrome	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Tremor	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	18.2% 2/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	50.0% 1/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Psychiatric disorders Confusional state	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	11.1% 3/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Psychiatric disorders Hallucination	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Candida infection	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Cellulitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Herpes zoster	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Pneumococcal sepsis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Skin infection	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Infections and infestations Vaginal infection	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Flushing	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Lymphoedema	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Vascular disorders Phlebitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Micturition urgency	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Bladder spasm	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Chronic kidney disease	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Urinary retention	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Renal and urinary disorders Urinary tract pain	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Eye disorders Blepharitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Eye disorders Eye swelling	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Eye disorders Eyelid oedema	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	10.5% 2/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Injury, poisoning and procedural complications Laceration	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Endocrine disorders Hyperthyroidism	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Endocrine disorders Thyroid mass	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	7.4% 2/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	9.1% 1/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Hepatobiliary disorders Jaundice	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Cardiac disorders Cardiac failure congestive	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	5.3% 1/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Cardiac disorders Tachycardia	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Immune system disorders Allergy to arthropod sting	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritoneal neoplasm	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	3.7% 1/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Nervous system disorders Encephalopathy	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/6 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/7 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	100.0% 1/1 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/2 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/19 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/27 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.	0.00% 0/11 • Baseline up to 30 days after last dose of study treatment (for Phase 1b: maximum up to 34.7 months, for Phase 2: maximum up to 13.5 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.

Additional Information

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