Trial Outcomes & Findings for Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Participants (NCT NCT04167137)

Last Updated: 2024-05-03

Results Overview

The following adverse events (AEs) were DLTs if they occurred in Cycle 1 and were assessed by the Investigator as related to treatment: 1. Grade (Gr) 4 nonhematologic toxicity (not laboratory) 2. Gr 4 hematologic toxicity ≥ 7 days, any Gr 4 thrombocytopenia, or Gr 3 thrombocytopenia with significant bleeding 3. Gr ≥ 3 nonhematologic toxicity (exceptions: Gr 3 fatigue ≤ 3 days; Gr 3 diarrhea, nausea, or vomiting without treatment; Gr 3 rash without treatment) 4. Gr 3/4 nonhematologic laboratory value for \> 1 week or resulting in significant medical intervention, hospitalization, or drug-induced liver injury (exceptions: clinically nonsignificant, treatable, or reversible laboratory abnormalities) 5. Gr 3/4 febrile neutropenia 6. Sepsis, severe abscesses and/or ulcerations requiring surgical management 7. Toxicity delaying Cycle 2 initiation \>2 weeks 8. Toxicity causing treatment discontinuation 9. Gr 3 toxicity causing omission of \> 33% of study doses 10. Gr 5 toxicity

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

21 days (1 cycle)

Results posted on

2024-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells) SYNB1891 was administered as an intratumoral (IT) injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg intravenously \[IV\] every 3 weeks \[Q3W\]) on Day 1 of each cycle.	Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.
Overall Study STARTED	3	3	4	5	3	6	4	4
Overall Study COMPLETED	1	1	1	0	1	0	0	0
Overall Study NOT COMPLETED	2	2	3	5	2	6	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells) SYNB1891 was administered as an intratumoral (IT) injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells) SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg intravenously \[IV\] every 3 weeks \[Q3W\]) on Day 1 of each cycle.	Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.
Overall Study Disease progression	1	1	3	3	2	3	2	2
Overall Study Withdrawal by Subject	1	0	0	1	0	2	1	0
Overall Study Adverse Event	0	0	0	0	0	1	0	1
Overall Study Physician Decision	0	0	0	1	0	0	1	0
Overall Study Death	0	1	0	0	0	0	0	0
Overall Study Study terminated by Sponsor	0	0	0	0	0	0	0	1

Baseline Characteristics

Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells) n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells) n=5 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells) n=6 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.	Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	21 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	11 Participants n=42 Participants
Age, Continuous	62.0 years n=5 Participants	58.0 years n=7 Participants	53.5 years n=5 Participants	57.0 years n=4 Participants	63.0 years n=21 Participants	74.5 years n=8 Participants	59.5 years n=8 Participants	60.5 years n=24 Participants	61.5 years n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	20 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	12 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	30 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	29 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	32 Participants n=42 Participants
Disease type Melanoma	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	8 Participants n=42 Participants
Disease type Sarcoma	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	5 Participants n=42 Participants
Disease type Esophageal cancer	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	4 Participants n=42 Participants
Disease type Squamous cell carcinoma (oropharynx)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Disease type Ampullary bile duct adenocarcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Basal cell carcinoma	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Cecum adenocarcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Colorectal cancer	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Endometrial cancer	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Jejunum adenocarcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Merkel cell carcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Non-small cell lung cancer	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Rectosigmoid adenocarcinoma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Small cell lung cancer	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Squamous cell carcinoma (skin)	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Squamous cell carcinoma (vulva)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Disease type Testicular cancer	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: 21 days (1 cycle)

Population: All participants who were enrolled, allocated to treatment, and received at least 1 dose of investigational product.

Outcome measures

Outcome measures
Measure	Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells) n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells) n=5 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells) n=6 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.	Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.
Number of Participants With Dose-limiting Toxicity	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 13 months

Population: All participants who were enrolled, allocated to treatment, and received at least 1 dose of investigational product.

Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, as follows: Grade 1 (mild/asymptomatic; no intervention); Grade 2 (moderate; minimal intervention); Grade 3 (severe/medically significant; hospitalization indicated; disabling); Grade 4 (life-threatening; urgent intervention required); or Grade 5 (fatal). Adverse events (AEs) were reported from clinical laboratory tests, vital sign and weight measurements, physical examinations, and any other medically indicated assessments, including participant interviews, from the time informed consent was signed through the end of the safety follow-up period. AEs were considered to be treatment-emergent adverse events (TEAEs) if they occurred or worsened in severity after the first dose of study treatment. TEAEs were considered treatment-related if the relationship to study drug was possibly, probably, or definitely related.

Outcome measures

Outcome measures
Measure	Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells) n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells) n=5 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells) n=6 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.	Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.
Number of Participants With Treatment-Emergent Adverse Events TEAE related to SYNB1891	3 Participants	1 Participants	2 Participants	3 Participants	3 Participants	6 Participants	2 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Maximum TEAE severity Grade 3	1 Participants	0 Participants	1 Participants	3 Participants	1 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Any TEAE	3 Participants	3 Participants	4 Participants	5 Participants	3 Participants	6 Participants	4 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events Maximum TEAE severity Grade 1	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Maximum TEAE severity Grade 2	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Maximum TEAE severity Grade 5	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Maximum TEAE severity Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events TEAE related to atezolizumab	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events TEAE leading to treatment withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 13 months

Population: All participants who received study drug and had an on-treatment response assessment (including "Not Evaluable") or who discontinued study before any response assessment was performed due to disease progression.

Appropriate imaging of the SYNB1891-injected tumor(s) and up to 5 target (noninjected) lesions was performed at baseline and every 2 cycles during the treatment period. Tumor response was assessed by the local investigator using RECIST 1.1 (Eisenhauer et al 2009). Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.

Outcome measures

Outcome measures
Measure	Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells) n=2 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells) n=2 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells) n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells) n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells) n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab n=4 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.	Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab n=3 Participants SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.
Number of Participants With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) SD	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) PD	1 Participants	1 Participants	3 Participants	3 Participants	2 Participants	2 Participants	3 Participants	1 Participants

Adverse Events

Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 1 deaths

Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells) n=3 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells) n=3 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells) n=4 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells) n=5 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells) n=3 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells) n=6 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab n=4 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.	Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab n=4 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	50.0% 3/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Constipation	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Infections and infestations Sepsis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Nervous system disorders Syncope	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Synovial sarcoma metastatic	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Nervous system disorders Transient ischaemic attack	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.

Other adverse events

Other adverse events
Measure	Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells) n=3 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells) n=3 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells) n=4 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells) n=5 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells) n=3 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells) n=6 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles.	Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab n=4 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.	Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab n=4 participants at risk SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles in combination with standard dose atezolizumab (1200 mg IV Q3W) on Day 1 of each cycle.
General disorders Chills	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	66.7% 2/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	66.7% 4/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	50.0% 2/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	50.0% 2/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Pyrexia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	50.0% 2/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	40.0% 2/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	50.0% 2/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Nausea	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	100.0% 3/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Nervous system disorders Headache	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Fatigue	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 2/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	75.0% 3/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	66.7% 2/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Constipation	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	50.0% 2/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Injection site pain	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	50.0% 2/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	66.7% 2/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Injection site reaction	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Activated Partial Thromboplastin Time Prolonged	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Aspartate Aminotransferase Increased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations International Normalised Ratio Increased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Infections and infestations Corona Virus Infection	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Infections and infestations Urinary Tract Infection	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	50.0% 3/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Vascular disorders Hypertension	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Vascular disorders Hypotension	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Psychiatric disorders Anxiety	66.7% 2/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Peripheral Swelling	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Blood Uric Acid Increased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Lymphocyte Count Decreased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Infections and infestations Conjunctivitis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Infections and infestations Pneumonia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Psychiatric disorders Insomnia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Nervous system disorders Ageusia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Cardiac disorders Atrial flutter	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Blood bilirubin increased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Blood creatinine increased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Cardiac disorders Bradycardia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Psychiatric disorders Confusional state	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Infections and infestations Cystitis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Nervous system disorders Dysgeusia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Face oedema	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Gait disturbance	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Vascular disorders Hot flush	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Hypoglycaemia	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Endocrine disorders Hypothyroidism	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Injection site discharge	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Injection site erythema	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Eye disorders Ocular hyperaemia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
General disorders Oedema peripheral	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Infections and infestations Oral candidiasis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Investigations Platelet count decreased	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Retching	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Cardiac disorders Tachycardia	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	20.0% 1/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	33.3% 1/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	16.7% 1/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.
Eye disorders Vision blurred	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	25.0% 1/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/5 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/3 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/6 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.	0.00% 0/4 • All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months. AE documentation included duration (onset and resolution dates), severity using the NCI CTCAE (version 5.0), assessment of causality, seriousness, and whether specific action or therapy was required. In summaries, preferred terms are counted only once per participant at the maximum reported grade.

Additional Information

Aoife Brennan, MB, BCh, BAO, MMSc

Synlogic

Phone: (857) 999-0767

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60