Trial Outcomes & Findings for A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors (NCT NCT04381650)

Last Updated: 2025-12-10

Results Overview

AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT Consensus Grading for CRS.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

161 participants

Primary outcome timeframe

Up to approximately 24 months

Results posted on

2025-12-10

Participant Flow

Participants took part in the study at various investigative sites throughout the world from 17 August 2020 to 29 October 2024.

Participants with a diagnosis of advanced or metastatic solid tumors were enrolled in this study consisting of Phase 1b (Dose Escalation cohorts), and Phase 2 (Dose Expansion cohorts) periods to receive TAK-981 and pembrolizumab.

Participant milestones

Participant milestones
Measure	Dose Escalation: TAK-981 40 mg Participants received TAK-981 40 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the recommended Phase 2 dose (RP2D) was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg Participants with non-squamous NSCLC received TAK-981 120 mg as IV infusion on Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg Participants with cervical cancer received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with microsatellite stable colorectal cancer (MSS-CRC) received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with checkpoint inhibitors (CPI) refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1b (Dose Escalation) STARTED	3	6	33	19	0	0	0	0	0	0	0
Phase 1b (Dose Escalation) COMPLETED	2	2	9	4	0	0	0	0	0	0	0
Phase 1b (Dose Escalation) NOT COMPLETED	1	4	24	15	0	0	0	0	0	0	0
Phase 2 (Dose Expansion) STARTED	0	0	0	0	14	9	21	9	28	15	4
Phase 2 (Dose Expansion) COMPLETED	0	0	0	0	8	5	17	2	23	4	1
Phase 2 (Dose Expansion) NOT COMPLETED	0	0	0	0	6	4	4	7	5	11	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation: TAK-981 40 mg Participants received TAK-981 40 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the recommended Phase 2 dose (RP2D) was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg Participants with non-squamous NSCLC received TAK-981 120 mg as IV infusion on Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg Participants with cervical cancer received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with microsatellite stable colorectal cancer (MSS-CRC) received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with checkpoint inhibitors (CPI) refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1b (Dose Escalation) New anti-cancer therapy	0	0	0	1	0	0	0	0	0	0	0
Phase 1b (Dose Escalation) Lost to Follow-up	0	0	0	1	0	0	0	0	0	0	0
Phase 1b (Dose Escalation) Progressive Disease	1	3	12	8	0	0	0	0	0	0	0
Phase 1b (Dose Escalation) Withdrawal by Subject	0	0	11	4	0	0	0	0	0	0	0
Phase 1b (Dose Escalation) Reason Not Specified	0	1	1	1	0	0	0	0	0	0	0
Phase 2 (Dose Expansion) New anti-cancer therapy	0	0	0	0	3	1	0	0	0	2	0
Phase 2 (Dose Expansion) Lost to Follow-up	0	0	0	0	0	0	0	1	1	1	0
Phase 2 (Dose Expansion) Progressive Disease	0	0	0	0	2	1	0	3	3	4	2
Phase 2 (Dose Expansion) Withdrawal by Subject	0	0	0	0	1	2	4	2	1	4	1
Phase 2 (Dose Expansion) Reason Not Specified	0	0	0	0	0	0	0	1	0	0	0

Baseline Characteristics

A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg n=14 Participants Participants with non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg n=9 Participants Participants with non-squamous NSCLC received TAK-981 120 mg as IV infusion on Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg n=21 Participants Participants with cervical cancer received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg n=9 Participants Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=15 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Total n=161 Participants Total of all reporting groups
Age, Continuous	66.0 years STANDARD_DEVIATION 5.57 • n=4 Participants	53.5 years STANDARD_DEVIATION 7.23 • n=50 Participants	56.2 years STANDARD_DEVIATION 11.91 • n=681 Participants	59.8 years STANDARD_DEVIATION 13.32 • n=639 Participants	63.3 years STANDARD_DEVIATION 10.83 • n=277 Participants	68.7 years STANDARD_DEVIATION 9.12 • n=294 Participants	51.8 years STANDARD_DEVIATION 13.24 • n=3238 Participants	49.6 years STANDARD_DEVIATION 9.22	55.9 years STANDARD_DEVIATION 13.95	67.5 years STANDARD_DEVIATION 7.66	73.5 years STANDARD_DEVIATION 3.70	58.5 years STANDARD_DEVIATION 12.82 • n=24 Participants
Sex: Female, Male Female	1 Participants n=4 Participants	5 Participants n=50 Participants	16 Participants n=681 Participants	8 Participants n=639 Participants	6 Participants n=277 Participants	5 Participants n=294 Participants	21 Participants n=3238 Participants	5 Participants	12 Participants	1 Participants	1 Participants	81 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	1 Participants n=50 Participants	17 Participants n=681 Participants	11 Participants n=639 Participants	8 Participants n=277 Participants	4 Participants n=294 Participants	0 Participants n=3238 Participants	4 Participants	16 Participants	14 Participants	3 Participants	80 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=4 Participants	1 Participants n=50 Participants	6 Participants n=681 Participants	1 Participants n=639 Participants	5 Participants n=277 Participants	0 Participants n=294 Participants	12 Participants n=3238 Participants	0 Participants	14 Participants	0 Participants	0 Participants	41 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=4 Participants	5 Participants n=50 Participants	25 Participants n=681 Participants	18 Participants n=639 Participants	8 Participants n=277 Participants	9 Participants n=294 Participants	9 Participants n=3238 Participants	9 Participants	14 Participants	14 Participants	4 Participants	116 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=50 Participants	2 Participants n=681 Participants	0 Participants n=639 Participants	1 Participants n=277 Participants	0 Participants n=294 Participants	0 Participants n=3238 Participants	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants	0 Participants n=639 Participants	0 Participants n=277 Participants	0 Participants n=294 Participants	0 Participants n=3238 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	4 Participants n=50 Participants	8 Participants n=681 Participants	7 Participants n=639 Participants	3 Participants n=277 Participants	1 Participants n=294 Participants	2 Participants n=3238 Participants	1 Participants	4 Participants	5 Participants	0 Participants	35 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants	0 Participants n=639 Participants	0 Participants n=277 Participants	0 Participants n=294 Participants	0 Participants n=3238 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=50 Participants	3 Participants n=681 Participants	1 Participants n=639 Participants	1 Participants n=277 Participants	0 Participants n=294 Participants	0 Participants n=3238 Participants	1 Participants	0 Participants	0 Participants	0 Participants	6 Participants n=24 Participants
Race (NIH/OMB) White	3 Participants n=4 Participants	2 Participants n=50 Participants	17 Participants n=681 Participants	9 Participants n=639 Participants	10 Participants n=277 Participants	8 Participants n=294 Participants	17 Participants n=3238 Participants	7 Participants	23 Participants	10 Participants	4 Participants	110 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants	0 Participants n=639 Participants	0 Participants n=277 Participants	0 Participants n=294 Participants	2 Participants n=3238 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=50 Participants	5 Participants n=681 Participants	2 Participants n=639 Participants	0 Participants n=277 Participants	0 Participants n=294 Participants	0 Participants n=3238 Participants	0 Participants	1 Participants	0 Participants	0 Participants	8 Participants n=24 Participants

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)	3 Participants	6 Participants	33 Participants	19 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Cycle 1 (each cycle was of 21 days)

Population: The DLT-evaluable Analysis Set included participants enrolled in Phase 1b of the study and who experienced a DLT at any time after receiving the first dose of TAK-981 during the DLT assessment period (Cycle 1) or who received all planned TAK-981 doses and 1 administration of pembrolizumab in Cycle 1.

DLTs were evaluated according to NCI CTCAE Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=30 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)	0 Participants	2 Participants	20 Participants	15 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Number of Participants With One or More Serious Adverse Events (SAEs)	0 Participants	3 Participants	17 Participants	10 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation TEAE Resulting in Dose Modifications of TAK-981	0 Participants	3 Participants	22 Participants	11 Participants	—	—	—	—	—	—	—
Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation TEAE Resulting in Drug Discontinuation of Pembrolizumab	0 Participants	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—
Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation TEAE Resulting in Dose Modifications of Pembrolizumab	0 Participants	3 Participants	15 Participants	4 Participants	—	—	—	—	—	—	—
Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation TEAE Resulting in Drug Discontinuation of TAK-981	0 Participants	1 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

Laboratory parameters included clinical chemistry, hematology, and urinalysis. Participants with at least 1 Grade 3 or 4 Lab Abnormalities were reported.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Number of Participants With Clinically Significant Laboratory Values Hematology	1 Participants	3 Participants	7 Participants	6 Participants	—	—	—	—	—	—	—
Phase 1: Number of Participants With Clinically Significant Laboratory Values Serum Chemistry	1 Participants	1 Participants	7 Participants	5 Participants	—	—	—	—	—	—	—
Phase 1: Number of Participants With Clinically Significant Laboratory Values Coagulation	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 25 months

Population: Response-Evaluable Analysis Set included participants who had received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or were discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.

ORR is defined as the percentage of participants who achieve Complete Response (CR) and Partial Response (PR) (determined by the investigator) during the study according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=10 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=8 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=20 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=9 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=13 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to RECIST, Version 1.1	20 percentage of participants Interval 2.52 to 55.61	0 percentage of participants Interval 0.0 to 36.94	30 percentage of participants Interval 11.89 to 54.28	0 percentage of participants Interval 0.0 to 33.63	25 percentage of participants Interval 10.69 to 44.87	7.7 percentage of participants Interval 0.19 to 36.03	0 percentage of participants Interval 0.0 to 60.24	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

Population: Pharmacokinetic (PK) Analysis Set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Number of participants analyzed is the number of participants available for analysis during the specified time-point.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Cmax: Maximum Observed Plasma Concentration for TAK-981 Cycle 1 Day 1	335 nanograms per milliliter (ng/ml) Standard Deviation 282	728 nanograms per milliliter (ng/ml) Standard Deviation 396	888 nanograms per milliliter (ng/ml) Standard Deviation 423	1290 nanograms per milliliter (ng/ml) Standard Deviation 571	—	—	—	—	—	—	—
Phase 1: Cmax: Maximum Observed Plasma Concentration for TAK-981 Cycle 1 Day 8	280 nanograms per milliliter (ng/ml) Standard Deviation 167	448 nanograms per milliliter (ng/ml) Standard Deviation 206	780 nanograms per milliliter (ng/ml) Standard Deviation 524	1270 nanograms per milliliter (ng/ml) Standard Deviation 770	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

Population: PK Analysis Set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Number of participants analyzed is the number of participants available for analysis during the specified time-point.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981 Cycle 1 Day 1	1.22 hours Interval 1.2 to 1.23	1.27 hours Interval 1.0 to 1.47	1.17 hours Interval 1.0 to 1.88	1.20 hours Interval 1.0 to 1.72	—	—	—	—	—	—	—
Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981 Cycle 1 Day 8	1.18 hours Interval 1.17 to 1.25	1.41 hours Interval 1.0 to 1.7	1.22 hours Interval 1.0 to 3.1	1.28 hours Interval 0.98 to 1.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

Population: PK Analysis Set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Overall number of participants analyzed is the number of participants with data available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=32 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=18 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981 Cycle 1 Day 1	880 hours*ng/mL Standard Deviation 427	1370 hours*ng/mL Standard Deviation 517	1950 hours*ng/mL Standard Deviation 735	2580 hours*ng/mL Standard Deviation 949	—	—	—	—	—	—	—
Phase 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981 Cycle 1 Day 8	814 hours*ng/mL Standard Deviation 290	976 hours*ng/mL Standard Deviation 232	1780 hours*ng/mL Standard Deviation 908	2640 hours*ng/mL Standard Deviation 1260	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=32 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=17 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981 Cycle 1 Day 1	909 hours*ng/mL Standard Deviation 432	1400 hours*ng/mL Standard Deviation 530	2020 hours*ng/mL Standard Deviation 760	2660 hours*ng/mL Standard Deviation 1020	—	—	—	—	—	—	—
Phase 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981 Cycle 1 Day 8	845 hours*ng/mL Standard Deviation 292	1010 hours*ng/mL Standard Deviation 233	1830 hours*ng/mL Standard Deviation 942	2750 hours*ng/mL Standard Deviation 1320	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=32 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=17 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: t1/2z: Terminal Disposition Phase Half-life for TAK-981 Cycle 1 Day 8	5.83 hours Interval 5.69 to 6.33	5.68 hours Interval 5.22 to 6.44	6.06 hours Interval 4.18 to 9.13	6.67 hours Interval 5.26 to 8.08	—	—	—	—	—	—	—
Phase 1: t1/2z: Terminal Disposition Phase Half-life for TAK-981 Cycle 1 Day 1	5.88 hours Interval 5.82 to 6.16	5.58 hours Interval 5.04 to 6.03	5.72 hours Interval 3.31 to 10.43	6.79 hours Interval 5.93 to 8.14	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=32 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=17 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: CL: Total Clearance After Intravenous Administration for TAK-981 Cycle 1 Day 1	51.1 liters per hour (L/h) Standard Deviation 23.2	47.2 liters per hour (L/h) Standard Deviation 14.8	51.3 liters per hour (L/h) Standard Deviation 19.6	51.0 liters per hour (L/h) Standard Deviation 18.4	—	—	—	—	—	—	—
Phase 1: CL: Total Clearance After Intravenous Administration for TAK-981 Cycle 1 Day 8	51.7 liters per hour (L/h) Standard Deviation 19.3	62.5 liters per hour (L/h) Standard Deviation 15.5	57.0 liters per hour (L/h) Standard Deviation 21.8	53.8 liters per hour (L/h) Standard Deviation 26.8	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=32 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=17 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 1: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-981 Cycle 1 Day 1	312 liters (L) Standard Deviation 203	181 liters (L) Standard Deviation 56.9	240 liters (L) Standard Deviation 115	240 liters (L) Standard Deviation 98.5	—	—	—	—	—	—	—
Phase 1: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-981 Cycle 1 Day 8	323 liters (L) Standard Deviation 178	314 liters (L) Standard Deviation 109	300 liters (L) Standard Deviation 129	271 liters (L) Standard Deviation 150	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months

DCR is defined as the percentage of participants who achieved stable disease (SD) or better (CR + PR + SD determined by the investigator) \>6 weeks during the trial in the response-evaluable population.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=18 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=10 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=8 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=20 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg n=9 Participants Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=13 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phases 1 and 2: Disease Control Rate (DCR)	33.3 percentage of participants Interval 0.84 to 90.57	50.0 percentage of participants Interval 11.81 to 88.19	30.3 percentage of participants Interval 15.59 to 48.71	44.4 percentage of participants Interval 21.53 to 69.24	80.0 percentage of participants Interval 44.39 to 97.48	62.5 percentage of participants Interval 24.49 to 91.48	55.0 percentage of participants Interval 31.53 to 76.94	22.2 percentage of participants Interval 2.81 to 60.01	67.9 percentage of participants Interval 47.65 to 84.12	30.8 percentage of participants Interval 9.09 to 61.43	0 percentage of participants Interval 0.0 to 60.24

SECONDARY outcome

Timeframe: Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months

DRR is defined as the rate of objective responses (CR + PR) maintained for at least 6 months initiating at any time within 12 months of commencing therapy.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=18 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=10 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=8 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=20 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg n=9 Participants Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=13 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phases 1 and 2: Durable Response Rate (DRR)	0 percentage of participants Interval 0.0 to 70.76	16.7 percentage of participants Interval 0.42 to 64.12	6.1 percentage of participants Interval 0.74 to 20.23	0 percentage of participants Interval 0.0 to 18.53	10.0 percentage of participants Interval 0.25 to 44.5	0 percentage of participants Interval 0.0 to 36.94	0 percentage of participants Interval 0.0 to 16.84	0 percentage of participants Interval 0.0 to 33.63	10.7 percentage of participants Interval 2.27 to 28.23	0 percentage of participants Interval 0.0 to 24.71	0 percentage of participants Interval 0.0 to 60.24

SECONDARY outcome

Timeframe: Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months

DOR is defined as a time from the time of first documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=1 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=3 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=1 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=1 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=2 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=3 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=1 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phases 1 and 2: Duration of Response (DOR)	—	17.12 hours Lower and upper limit of 95% Confidence Interval was not estimable for a single participant.	7.39 hours Interval 4.17 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	3.71 hours Lower and upper limit of 95% Confidence Interval was not estimable for a single participant.	7.62 hours Lower and upper limit of 95% Confidence Interval was not estimable for a single participant.	—	NA hours Interval 4.67 to Median and upper limit of 95% Confidence Interval was not estimable due to censoring.	—	NA hours Interval 7.26 to Median and upper limit of 95% Confidence Interval was not estimable due to censoring.	4.34 hours Lower and upper limit of 95% Confidence Interval was not estimable for a single participant.	—

SECONDARY outcome

Timeframe: Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months

PFS is defined as time from the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=5 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=28 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=16 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=8 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=7 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=15 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg n=8 Participants Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=17 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=11 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phases 1 and 2: Progression-free Survival (PFS)	2.00 months Interval 2.0 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	4.21 months Interval 2.0 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	1.99 months Interval 1.77 to 3.91	2.11 months Interval 1.41 to 6.57	3.71 months Interval 3.29 to 9.2	4.59 months Interval 1.97 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	4.14 months Interval 2.14 to 8.87	1.64 months Interval 1.28 to 2.0	8.97 months Interval 2.37 to 12.42	2.07 months Interval 1.87 to 2.3	1.28 months Interval 0.99 to Upper limit of 95% Confidence Interval was not estimable due to censoring.

SECONDARY outcome

Timeframe: Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months

TTR is defined as time from the date of the first dose administration to the date of first documented PR or better.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=2 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=3 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=1 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=2 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=6 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=7 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=1 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phases 1 and 2: Time to Response (TTR)	—	4.17 months Interval 1.91 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	NA months Interval 3.94 to Median and Upper limit of 95% Confidence Interval was not estimable due to censoring.	NA months Median, lower limit and upper limit of 95% CI was not estimable due to censoring.	4.01 months Interval 3.98 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	—	6.01 months Interval 4.04 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	—	NA months Median, lower limit and upper limit of 95% CI was not estimable due to censoring.	NA months Median, lower limit and upper limit of 95% CI was not estimable due to censoring.	—

SECONDARY outcome

Timeframe: Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months

TTP is defined as the from the date of the first dose administration to the date of the first documentation of PD as defined by standard disease criteria.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=5 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=25 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=15 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=8 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=6 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=13 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg n=6 Participants Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=14 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=11 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phases 1 and 2: Time to Progression (TTP)	2.00 months Interval 2.0 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	4.21 months Interval 2.0 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	2.07 months Interval 1.87 to 4.04	2.07 months Interval 1.41 to 6.93	3.71 months Interval 3.29 to 9.2	4.01 months Interval 1.97 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	5.34 months Interval 2.2 to 8.87	1.76 months Interval 1.28 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	9.17 months Interval 4.11 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	2.07 months Interval 1.87 to 2.3	1.28 months Interval 0.99 to Upper limit of 95% Confidence Interval was not estimable due to censoring.

SECONDARY outcome

Timeframe: Up to approximately 25 months

OS is defined as the time from the date of the first dose administration to the date of death. Participants without documentation of death at the time of analysis were censored at the date last known to be alive.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=1 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=4 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=9 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=2 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=8 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=1 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=1 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 2: Overall Survival (OS)	NA months Median, Lower limit and Upper limit of 95% CI was not estimable due to censoring.	10.12 months Interval 5.16 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	14.55 months Interval 5.42 to Upper limit of 95% Confidence Interval was not estimable due to censoring.	NA months Interval 4.21 to Median and Upper limit of 95% CI was not estimable due to censoring.	NA months Interval 11.43 to Median and Upper limit of 95% CI was not estimable due to censoring.	NA months Median and Upper limit of 95% CI was not estimable due to censoring.	NA months Interval 1.28 to Median and Upper limit of 95% CI was not estimable due to censoring.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (1 hour, 4 hours, 8 hours) and Day 8 (Pre-dose, 1 hour, 4 hours and 8 hours) (Cycle length = 21 days)

Population: Pharmacodynamic Analysis Set included participants who provided evaluable blood samples (Cycle 1, Day 1 predose sample and at least 1 postdose sample). Overall number of participants analyzed is the number of participants with data available for analysis. Number of participants analyzed is the number of participants available for analysis during the specified time-point.

The level of TAK-981-SUMO adduct formation was evaluated by flow cytometry as the percentage of adduct formed in peripheral blood lymphocytes. Fold change from baseline was calculated as: Post-treatment value / Baseline value. Positive change denotes improvement.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=18 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=13 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Fold Change From Baseline in TAK-981-/Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 1: 1 Hour Post Dose	8.1 unitless ratio Standard Deviation 1.06	7.0 unitless ratio Standard Deviation 3.12	8.5 unitless ratio Standard Deviation 3.38	8.4 unitless ratio Standard Deviation 2.40	—	—	—	—	—	—	—
Fold Change From Baseline in TAK-981-/Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 1: 4 Hours Post Dose	5.1 unitless ratio Standard Deviation 0.82	5.0 unitless ratio Standard Deviation 1.90	6.0 unitless ratio Standard Deviation 1.80	6.3 unitless ratio Standard Deviation 1.70	—	—	—	—	—	—	—
Fold Change From Baseline in TAK-981-/Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 1: 6-8 Hours Post Dose	4.6 unitless ratio Standard Deviation 0.61	4.5 unitless ratio Standard Deviation 1.87	5.3 unitless ratio Standard Deviation 1.58	5.5 unitless ratio Standard Deviation 1.29	—	—	—	—	—	—	—
Fold Change From Baseline in TAK-981-/Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 8: Predose	3.5 unitless ratio Standard Deviation 0.53	2.6 unitless ratio Standard Deviation 0.96	2.7 unitless ratio Standard Deviation 1.43	2.0 unitless ratio Standard Deviation 0.68	—	—	—	—	—	—	—
Fold Change From Baseline in TAK-981-/Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 8: 1 Hour Post Dose	11.9 unitless ratio Standard Deviation 3.52	7.7 unitless ratio Standard Deviation 2.88	9.2 unitless ratio Standard Deviation 4.68	8.7 unitless ratio Standard Deviation 2.01	—	—	—	—	—	—	—
Fold Change From Baseline in TAK-981-/Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 8: 4 Hours Post Dose	7.5 unitless ratio Standard Deviation 1.52	6.0 unitless ratio Standard Deviation 2.66	6.4 unitless ratio Standard Deviation 2.90	6.1 unitless ratio Standard Deviation 2.12	—	—	—	—	—	—	—
Fold Change From Baseline in TAK-981-/Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 8: 6-8 Hours Post Dose	6.5 unitless ratio Standard Deviation 1.08	5.1 unitless ratio Standard Deviation 2.30	5.7 unitless ratio Standard Deviation 2.64	5.6 unitless ratio Standard Deviation 1.96	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (1 hour, 4 hours, 8 hours) and Day 8 (Pre-dose, 1 hour, 4 hours and 8 hours) (Cycle length = 21 days)

SUMO pathway inhibition in blood was evaluated by flow cytometry in peripheral blood lymphocytes with an antibody recognizing SUMO 2/3 chains. Fold change from baseline was calculated as: Post-treatment value / Baseline value.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=3 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=18 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=13 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Fold Change From Baseline in SUMO 2/3 Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 8: 1 Hour Post Dose	0.6 unitless ratio Standard Deviation 0.14	0.6 unitless ratio Standard Deviation 0.23	0.7 unitless ratio Standard Deviation 0.34	0.4 unitless ratio Standard Deviation 0.15	—	—	—	—	—	—	—
Fold Change From Baseline in SUMO 2/3 Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 8: 4 Hours Post Dose	0.7 unitless ratio Standard Deviation 0.22	0.6 unitless ratio Standard Deviation 0.15	0.8 unitless ratio Standard Deviation 0.58	0.5 unitless ratio Standard Deviation 0.17	—	—	—	—	—	—	—
Fold Change From Baseline in SUMO 2/3 Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 8: 6-8 Hours Post Dose	0.7 unitless ratio Standard Deviation 0.29	0.6 unitless ratio Standard Deviation 0.11	0.9 unitless ratio Standard Deviation 0.53	0.6 unitless ratio Standard Deviation 0.22	—	—	—	—	—	—	—
Fold Change From Baseline in SUMO 2/3 Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 1: 4 Hours Post Dose	0.8 unitless ratio Standard Deviation 0.07	0.6 unitless ratio Standard Deviation 0.12	0.9 unitless ratio Standard Deviation 0.54	0.6 unitless ratio Standard Deviation 0.11	—	—	—	—	—	—	—
Fold Change From Baseline in SUMO 2/3 Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 1: 6-8 Hours Post Dose	0.8 unitless ratio Standard Deviation 0.08	0.7 unitless ratio Standard Deviation 0.19	1.0 unitless ratio Standard Deviation 0.68	0.7 unitless ratio Standard Deviation 0.34	—	—	—	—	—	—	—
Fold Change From Baseline in SUMO 2/3 Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 8: Predose	0.9 unitless ratio Standard Deviation 0.24	1.0 unitless ratio Standard Deviation 0.35	0.9 unitless ratio Standard Deviation 0.36	0.7 unitless ratio Standard Deviation 0.39	—	—	—	—	—	—	—
Fold Change From Baseline in SUMO 2/3 Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 1: 1 Hour Post Dose	0.7 unitless ratio Standard Deviation 0.14	0.6 unitless ratio Standard Deviation 0.21	0.6 unitless ratio Standard Deviation 0.18	0.5 unitless ratio Standard Deviation 0.08	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 25 months

Population: Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=14 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=9 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=21 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=9 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=15 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 2: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs)	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	93.3 percentage of participants	100 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 25 months

Population: Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

An AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT Consensus Grading for CRS.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=14 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=9 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=21 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=9 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=15 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 2: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)	7 Participants	5 Participants	18 Participants	8 Participants	14 Participants	4 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 25 months

Population: Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-981 40 mg n=14 Participants Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=9 Participants Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=21 Participants Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=9 Participants Participants received TAK-981 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 Participants Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=15 Participants Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg n=4 Participants Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous and Non-squamous NSCLC TAK-981 90 mg Participants with CPI refractory squamous and non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Phase 2: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation TEAE Resulting in Dose Modifications of TAK-981	11 Participants	6 Participants	15 Participants	5 Participants	15 Participants	6 Participants	4 Participants	—	—	—	—
Phase 2: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation TEAE Resulting in Dose Modifications of Pembrolizumab	7 Participants	5 Participants	12 Participants	4 Participants	13 Participants	2 Participants	4 Participants	—	—	—	—
Phase 2: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation TEAE Resulting in Drug Discontinuation of TAK-981	1 Participants	1 Participants	6 Participants	0 Participants	6 Participants	1 Participants	0 Participants	—	—	—	—
Phase 2: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation TEAE Resulting in Drug Discontinuation of Pembrolizumab	1 Participants	3 Participants	4 Participants	0 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—

Adverse Events

Dose Escalation: TAK-981 40 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Dose Escalation: TAK-981 60 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 2 deaths

Dose Escalation: TAK-981 90 mg

Serious events: 17 serious events

Other events: 33 other events

Deaths: 8 deaths

Dose Escalation: TAK-981 120 mg

Serious events: 10 serious events

Other events: 19 other events

Deaths: 4 deaths

Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg

Serious events: 3 serious events

Other events: 14 other events

Deaths: 2 deaths

Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg

Serious events: 4 serious events

Other events: 9 other events

Deaths: 4 deaths

Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg

Serious events: 11 serious events

Other events: 21 other events

Deaths: 9 deaths

Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg

Serious events: 4 serious events

Other events: 9 other events

Deaths: 2 deaths

Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg

Serious events: 14 serious events

Other events: 28 other events

Deaths: 8 deaths

Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg

Serious events: 5 serious events

Other events: 14 other events

Deaths: 2 deaths

Dose Expansion: Cohort F: CPI Refractory Squamous or Non-squamous NSCLC TAK-981 90 mg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation: TAK-981 40 mg n=3 participants at risk Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 participants at risk Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 participants at risk Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 participants at risk Participants received TAK-981, 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg n=14 participants at risk Participants with non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg n=9 participants at risk Participants with non-squamous NSCLC received TAK-981 120 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg n=21 participants at risk Participants with cervical cancer received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg n=9 participants at risk Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 participants at risk Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=15 participants at risk Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous or Non-squamous NSCLC TAK-981 90 mg n=4 participants at risk Participants with CPI refractory squamous or non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Immune system disorders Anaphylactic shock	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Vascular disorders Aortic aneurysm rupture	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Aplasia pure red cell	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Arrhythmia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Ascites	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Atrioventricular block	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Bronchitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Cholangitis acute	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Dermatomyositis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Device related thrombosis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Fatigue	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Gastroenteritis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Vascular disorders Hypotension	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Intestinal perforation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Ischaemic stroke	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Malaise	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Malignant biliary obstruction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Orchitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Psychiatric disorders Mental status changes	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Non-cardiac chest pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Oedema peripheral	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Platelet count decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Pneumonia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Pneumonia bacterial	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Pyrexia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Sepsis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Spinal cord compression	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Transfusion-related acute lung injury	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Urinary tract infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

Other adverse events

Other adverse events
Measure	Dose Escalation: TAK-981 40 mg n=3 participants at risk Participants received TAK-981 40 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 60 mg n=6 participants at risk Participants received TAK-981 60 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 90 mg n=33 participants at risk Participants received TAK-981 90 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Escalation: TAK-981 120 mg n=19 participants at risk Participants received TAK-981, 120 mg, IV infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg n=14 participants at risk Participants with non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg n=9 participants at risk Participants with non-squamous NSCLC received TAK-981 120 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort B: Cervical Cancer TAK-981 90 mg n=21 participants at risk Participants with cervical cancer received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort C: MSS-CRC TAK-981 90 mg n=9 participants at risk Participants with MSS-CRC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort D: Cutaneous Melanoma TAK-981 90 mg n=28 participants at risk Participants with cutaneous melanoma received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort E: Squamous NSCLC TAK-981 90 mg n=15 participants at risk Participants with squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.	Dose Expansion: Cohort F: CPI Refractory Squamous or Non-squamous NSCLC TAK-981 90 mg n=4 participants at risk Participants with CPI refractory squamous or non-squamous NSCLC received TAK-981 90 mg as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 3/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	23.8% 5/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 3/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.7% 3/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Abnormal weight gain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Psychiatric disorders Agitation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.2% 7/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 4/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	19.0% 4/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	48.5% 16/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	31.6% 6/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.4% 3/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	61.9% 13/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 3/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 7/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	13.3% 2/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	50.0% 2/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Anaemia of malignant disease	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Anal fissure	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Angina pectoris	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Angular cheilitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Psychiatric disorders Anxiety	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	66.7% 2/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 2/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.2% 5/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.8% 3/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 4/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	19.0% 4/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	17.9% 5/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Ascites	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	39.4% 13/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 4/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	44.4% 4/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	19.0% 4/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.7% 3/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Asthenia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 3/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	19.0% 4/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	20.0% 3/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Atrial flutter	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.4% 3/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Balance disorder	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Balanitis candida	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.2% 5/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	19.0% 4/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Blood bilirubin increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Blood creatinine increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	17.9% 5/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Blood pressure increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Brain natriuretic peptide increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Burning sensation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations C-reactive protein increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	50.0% 2/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations CD4 lymphocytes decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 3/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations COVID-19	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.4% 3/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Cardiac failure	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Chills	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	36.4% 12/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	57.9% 11/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	35.7% 5/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 4/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Chromaturia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Constipation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 3/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.1% 4/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 3/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	35.7% 10/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Cystitis noninfective	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	30.3% 10/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	31.6% 6/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	44.4% 4/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	19.0% 4/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 3/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	17.9% 5/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	75.0% 3/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Defaecation urgency	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Dengue fever	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Psychiatric disorders Depression	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 4/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	27.3% 9/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	47.4% 9/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.4% 3/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 7/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 3/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 7/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	20.0% 3/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Eye disorders Diplopia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Dizziness	33.3% 1/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Eye disorders Dry eye	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.4% 3/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Dysgeusia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.2% 5/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.1% 4/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	50.0% 2/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Dysuria	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Early satiety	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Ejection fraction decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Electrocardiogram ST-T segment abnormal	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Reproductive system and breast disorders Epididymal cyst	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Eye infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Fatigue	66.7% 2/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	39.4% 13/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.1% 4/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	35.7% 5/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	55.6% 5/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 6/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	55.6% 5/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	32.1% 9/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Feeling cold	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Gastroenteritis norovirus	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Gastrointestinal infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders General physical health deterioration	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Haematuria	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Psychiatric disorders Hallucination	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Headache	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	18.2% 6/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.1% 4/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.4% 3/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	17.9% 5/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Herpes simplex reactivation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Herpes zoster	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Vascular disorders Hot flush	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Vascular disorders Hypertension	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.7% 3/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.7% 3/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	13.3% 2/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	75.0% 3/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	26.3% 5/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	13.3% 2/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Vascular disorders Hypotension	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	23.8% 5/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Influenza	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Influenza like illness	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.8% 3/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.2% 7/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Infusion site extravasation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Injection site erythema	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Injection site pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Psychiatric disorders Insomnia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Interleukin level increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Intestinal polyp	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Kidney infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Large intestine polyp	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Leukocyturia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Psychiatric disorders Libido decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Lip oedema	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Lipase increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Localised oedema	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Lymphocyte count decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	19.0% 4/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.7% 3/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	13.3% 2/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Malaise	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	12.1% 4/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.1% 3/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 3/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	17.9% 5/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Nausea	33.3% 1/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	24.2% 8/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	26.3% 5/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.4% 3/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	66.7% 6/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	42.9% 9/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	46.4% 13/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system neoplasm	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 4/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Neutrophil count decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Non-cardiac chest pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Eye disorders Ocular hyperaemia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Oedema peripheral	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.8% 3/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	17.9% 5/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Oral candidiasis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Injury, poisoning and procedural complications Oral contusion	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Oral herpes	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.8% 3/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Orchitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Palpitations	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Paraesthesia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Paronychia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Parosmia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Paroxysmal arrhythmia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Reproductive system and breast disorders Penile oedema	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Reproductive system and breast disorders Perineal pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Peripheral swelling	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Platelet count decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	18.2% 6/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.8% 3/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Pneumonia	33.3% 1/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Polyneuropathy	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Vascular disorders Poor peripheral circulation	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Procalcitonin increased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	15.8% 3/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.4% 6/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Pulpitis dental	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Pyrexia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	51.5% 17/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	73.7% 14/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	64.3% 9/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	44.4% 4/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	52.4% 11/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 3/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	39.3% 11/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	40.0% 6/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.1% 4/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 3/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.7% 3/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Renal impairment	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Restless legs syndrome	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations SARS-CoV-2 test positive	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Seizure	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Sinusitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Skin candida	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Skin infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Somnolence	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Steroid diabetes	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	24.2% 8/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	42.1% 8/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 4/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	33.3% 3/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 8/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
General disorders Swelling face	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations T-lymphocyte count decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.1% 4/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 2/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Tinea pedis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Tongue ulceration	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Nervous system disorders Tremor	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 2/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Urethritis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.6% 1/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Urinary tract infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	12.1% 4/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 6/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	17.9% 5/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	5.3% 1/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Vascular disorders Vasculitis	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Viral infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	3.0% 1/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	16.7% 1/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Eye disorders Visual acuity reduced	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	7.1% 1/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	4.8% 1/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 7/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Gastrointestinal disorders Vomiting	66.7% 2/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	21.2% 7/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	26.3% 5/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	28.6% 4/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	23.8% 5/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	22.2% 2/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 4/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.7% 1/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	25.0% 1/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations Weight decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	10.5% 2/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	9.5% 2/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	11.1% 1/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.
Investigations White blood cell count decreased	0.00% 0/3 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/6 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	6.1% 2/33 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/19 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/14 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	14.3% 3/21 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/9 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/28 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/15 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.	0.00% 0/4 • Phase 1: Up to approximately 24 months, Phase 2: Up to approximately 25 months Safety Analysis Set included participants who received at least 1 dose, even if incomplete, of study drug.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place