Trial Outcomes & Findings for A Study Of PF-06647263 In Patients With Advanced Solid Tumors (NCT NCT02078752)

NCT ID: NCT02078752

Last Updated: 2019-04-29

Results Overview

DLTs were defined as any of the following adverse events (AEs) which were not considered related to disease progression occurring in the first cycle of treatment:(1)Hematologic: grade 4 neutropenia lasting \>7 days; febrile neutropenia (defined as neutropenia \>=Grade 3 and a single body temperature \>38.3°C or a sustained temperature of \>=38°C for more than 1 hour); grade \>=3 neutropenia with infection; any grade thrombocytopenia associated with clinically significant or life threatening bleeding; grade 4 thrombocytopenia \>=72 hours or platelets \<=10,000/mm\^3 regardless of duration. (2)Non- hematologic: bilirubin increase \>=2 × upper limit of normal (ULN) and not related to disease progression or other known cause; all other Grade \>=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); delay by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

Baseline up to Cycle 2 Day 1 (22 days)

Results posted on

2019-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	PF-06647263 0.01 mg/kg QW (Part 1) Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.075 mg/kg Q3W (Part 1) Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Study STARTED	3	13	2	7	3	9	3	6	2	12
Overall Study COMPLETED	1	6	1	5	2	5	1	3	2	2
Overall Study NOT COMPLETED	2	7	1	2	1	4	2	3	0	10

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-06647263 0.01 mg/kg QW (Part 1) Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.075 mg/kg Q3W (Part 1) Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Overall Study Death	0	3	0	0	0	1	0	1	4
Overall Study Lost to Follow-up	1	0	0	1	0	0	0	0	0
Overall Study Withdrawal by Subject	1	1	1	1	0	3	2	1	1
Overall Study Other	0	3	0	0	1	0	0	1	0
Overall Study Study terminated by sponsor	0	0	0	0	0	0	0	0	5

Baseline Characteristics

A Study Of PF-06647263 In Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg QW (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	Total n=60 Participants Total of all reporting groups
Age, Customized 18-44	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants
Age, Customized 45-64	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants	38 Participants n=42 Participants
Age, Customized >=65	1 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	18 Participants n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	12 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=10 Participants	2 Participants n=115 Participants	4 Participants n=24 Participants	2 Participants n=42 Participants	12 Participants n=42 Participants	54 Participants n=42 Participants
Sex: Female, Male Male	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	2 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	11 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants	2 Participants n=115 Participants	6 Participants n=24 Participants	2 Participants n=42 Participants	10 Participants n=42 Participants	48 Participants n=42 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants
Race/Ethnicity, Customized 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	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Other	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=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Unspecified	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline up to Cycle 2 Day 1 (22 days)

Population: The analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Dose Limiting Toxicities (DLTs) (Part 1)	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	—	0 Participants

PRIMARY outcome

Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Population: The analysis set included all treated participants in Part 2 with measurable disease at baseline.

Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=12 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Percentage of Participants With Objective Response (Part 2)	—	—	—	—	—	—	—	—	—	8.3 Percentage of Participants Interval 0.2 to 38.5

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last treatment administration (Approximately 13 months)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causality, All Cycles)	3 Participants	6 Participants	13 Participants	2 Participants	7 Participants	3 Participants	9 Participants	2 Participants	12 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last treatment administration (Approximately 13 months)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Treatment-Emergent AEs (Treatment-related, All Cycles)	3 Participants	5 Participants	11 Participants	2 Participants	7 Participants	3 Participants	9 Participants	2 Participants	8 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last treatment administration (Approximately 13 months)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) (All Causality, All Cycles)	1 Participants	3 Participants	6 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to 28 days after the last treatment administration (Approximately 13 months)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Treatment-Emergent SAEs (Treatment-related, All Cycles)	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Days 1, 8, 15 of each cycle, and post treatment period. (Approximately 13 months)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Following parameters were analyzed for examination of vital signs: sitting systolic and diastolic blood pressure (SBP \& DBP), and sitting pulse rate. The abnormal criteria were: (1) minimum SBP \<90mmHg; (2) SBP change from baseline, maximum decrease \>=30mmHg or maximum increase \>=30mmHg; (3) minimum DBP \<50mmHg; (4) DBP change from baseline, maximum decrease \>=20mmHg or maximum increase \>=20mmHg; (5) minimum supine pulse rate \<40 BPM or maximum supine pulse rate \>120 BPM.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Vital Signs Abnormalities Sitting pulse rate <40	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Max decrease from baseline in sitting SBP >=30	2 Participants	2 Participants	5 Participants	2 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Vital Signs Abnormalities Sitting systolic blood pressure (SBP) <90	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Sitting diastolic blood pressure (DBP) <50	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Vital Signs Abnormalities Sitting pulse rate >120	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Vital Signs Abnormalities Max increase from baseline in sitting SBP >=30	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Max increase from baseline in sitting DBP >=20	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Max decrease from baseline in sitting DBP >=20	2 Participants	2 Participants	3 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).

Population: The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.

AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=10 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=8 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Area Under the Serum Concentration-time Profile From Time 0 to the 504-hour Time Point (AUC504) of PF-06647263	—	—	2777 ng*hr/mL Geometric Coefficient of Variation 26	3958 ng*hr/mL Geometric Coefficient of Variation 45	3414 ng*hr/mL Geometric Coefficient of Variation 23	—	—	—	—	2299 ng*hr/mL Geometric Coefficient of Variation 41

SECONDARY outcome

Timeframe: QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Population: "Number of Participants Analyzed" represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. "Number Analyzed" represents the number of participants contributing to the PK parameter summary statistics at that time point.

Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263 Cycle 1 Day 1	6023 ng*hr/mL Geometric Coefficient of Variation 35	6363 ng*hr/mL Geometric Coefficient of Variation 18	544.8 ng*hr/mL Geometric Coefficient of Variation 28	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were :458 and 1360	1056 ng*hr/mL Geometric Coefficient of Variation 31	1246 ng*hr/mL Geometric Coefficient of Variation 56	3475 ng*hr/mL Geometric Coefficient of Variation 36	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 8060 and 13400	669.9 ng*hr/mL Geometric Coefficient of Variation 31	594.1 ng*hr/mL Geometric Coefficient of Variation 38
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263 Cycle 1 Day 15	—	—	1166 ng*hr/mL Geometric Coefficient of Variation 37	—	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 1370 and 1570	—	—	—	1274 ng*hr/mL Geometric Coefficient of Variation 30	927.8 ng*hr/mL Geometric Coefficient of Variation 33
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263 Cycle 4 Day 1	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 10200.	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 6820.	—	—	—	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 1800 and 1900.	4617 ng*hr/mL Geometric Coefficient of Variation 42	—	—	—

SECONDARY outcome

Maximum observed serum concentration Cmax was determined directly from data. In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Maximum Observed Serum Concentration (Cmax) of PF-06647263 Cycle 1 Day 1	84.40 ng/mL Geometric Coefficient of Variation 38	101.6 ng/mL Geometric Coefficient of Variation 34	11.96 ng/mL Geometric Coefficient of Variation 26	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 12.8 and 21.8.	22.63 ng/mL Geometric Coefficient of Variation 24	25.41 ng/mL Geometric Coefficient of Variation 60	58.25 ng/mL Geometric Coefficient of Variation 40	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 131 and 154.	16.86 ng/mL Geometric Coefficient of Variation 29	12.64 ng/mL Geometric Coefficient of Variation 20
Maximum Observed Serum Concentration (Cmax) of PF-06647263 Cycle 1 Day 15	—	—	13.73 ng/mL Geometric Coefficient of Variation 47	—	27.45 ng/mL Geometric Coefficient of Variation 48	—	—	—	17.84 ng/mL Geometric Coefficient of Variation 25	11.86 ng/mL Geometric Coefficient of Variation 33
Maximum Observed Serum Concentration (Cmax) of PF-06647263 Cycle 4 Day 1	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 47.7 and 80.9.	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 67.7 and 43.8.	—	—	—	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 21.2 and 18.1.	41.98 ng/mL Geometric Coefficient of Variation 16	—	—	—

SECONDARY outcome

Tmax was determined directly from data as time of first occurrence. In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Time for Cmax (Tmax) of PF-06647963 Cycle 1 Day 1	3.97 hr Interval 1.05 to 4.05	1.05 hr Interval 1.0 to 1.12	1.00 hr Interval 1.0 to 4.0	2.52 hr Interval 1.0 to 4.03	1.00 hr Interval 1.0 to 4.0	1.00 hr Interval 1.0 to 1.05	1.00 hr Interval 0.85 to 4.0	1.03 hr Interval 1.02 to 1.03	1.00 hr Interval 1.0 to 4.0	1.00 hr Interval 1.0 to 1.0
Time for Cmax (Tmax) of PF-06647963 Cycle 1 Day 15	—	—	1.00 hr Interval 1.0 to 1.0	—	1.00 hr Interval 1.0 to 1.0	—	—	—	1.00 hr Interval 1.0 to 1.0	1.00 hr Interval 1.0 to 1.0
Time for Cmax (Tmax) of PF-06647963 Cycle 4 Day 1	2.60 hr Interval 1.07 to 4.13	1.56 hr Interval 1.05 to 2.07	—	—	—	2.55 hr Interval 1.0 to 4.1	1.08 hr Interval 1.0 to 4.0	—	—	—

SECONDARY outcome

Timeframe: QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Clearance (CL) of PF-06647263 Cycle 1 Day 1	0.9244 L/hr Geometric Coefficient of Variation 43	0.9219 L/hr Geometric Coefficient of Variation 39	—	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 0.938.	—	1.547 L/hr Geometric Coefficient of Variation 33	1.108 L/hr Geometric Coefficient of Variation 24	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 1.06 and 0.807.	—	—
Clearance (CL) of PF-06647263 Cycle 1 Day 15	—	—	0.9454 L/hr Geometric Coefficient of Variation 31	—	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 0.699 and 0.868.	—	—	—	0.8451 L/hr Geometric Coefficient of Variation 27	0.7932 L/hr Geometric Coefficient of Variation 15
Clearance (CL) of PF-06647263 Cycle 4 Day 1	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 0.441.	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 0.601.	—	—	—	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 0.944 and 1.47.	0.6904 L/hr Geometric Coefficient of Variation 36	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Volume of Distribution at Steady State (Vss) of PF-06647263 Cycle 1 Day 1	134.0 L Geometric Coefficient of Variation 49	116.5 L Geometric Coefficient of Variation 56	—	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 116.	—	162.7 L Geometric Coefficient of Variation 44	114.8 L Geometric Coefficient of Variation 20	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value were 128 and 159.	—	—
Volume of Distribution at Steady State (Vss) of PF-06647263 Cycle 1 Day 15	—	—	102.3 L Geometric Coefficient of Variation 49	—	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 96.1.	—	—	—	72.31 L Geometric Coefficient of Variation 21	84.01 L Geometric Coefficient of Variation 28
Volume of Distribution at Steady State (Vss) of PF-06647263 Cycle 4 Day 1	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. One of the individual values was 84.6. The other was not reported because CL value did not meet reporting criteria.	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. One of the individual values was 109. The other was not reported because CL value did not meet reporting criteria.	—	—	—	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 123 and 187.	105.7 L Geometric Coefficient of Variation 18	—	—	—

SECONDARY outcome

Timeframe: Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=2 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Terminal Serum Half-life (t1/2) of PF-06647263 Cycle 1 Day 1	—	—	4.403 day Standard Deviation 0.593	3.541 day Standard Deviation 0.756	5.353 day Standard Deviation 0.542	4.336 day Standard Deviation 1.02	NA day Standard Deviation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value were 5.16 and 5.28.	—	—	NA day Standard Deviation NA Individual values are reported when fewer than 3 participants had report able parameter values.. The individual value was 4.76.
Terminal Serum Half-life (t1/2) of PF-06647263 Cycle 4 Day 1	—	—	NA day Standard Deviation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 4.16 and 4.22.	5.100 day Standard Deviation 1.56	NA day Standard Deviation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 4.93 and 5.79.	NA day Standard Deviation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 4.77 and 6.07.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).

Population: The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.

AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=11 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=4 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=8 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
AUC504 of Total Antibody	—	—	64190 ng*hr/mL Geometric Coefficient of Variation 26	91730 ng*hr/mL Geometric Coefficient of Variation 19	74250 ng*hr/mL Geometric Coefficient of Variation 40	—	—	—	—	50080 ng*hr/mL Geometric Coefficient of Variation 38

SECONDARY outcome

Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
AUCtau of Total Antibody Cycle 1 Day 1	173000 ng*hr/mL Geometric Coefficient of Variation 39	164400 ng*hr/mL Geometric Coefficient of Variation 22	11780 ng*hr/mL Geometric Coefficient of Variation 32	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 10500 and 38500.	18900 ng*hr/mL Geometric Coefficient of Variation 26	38330 ng*hr/mL Geometric Coefficient of Variation 63	81710 ng*hr/mL Geometric Coefficient of Variation 45	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 191000 and 419000.	13950 ng*hr/mL Geometric Coefficient of Variation 29	12140 ng*hr/mL Geometric Coefficient of Variation 29
AUCtau of Total Antibody Cycle 1 Day 15	—	—	29740 ng*hr/mL Geometric Coefficient of Variation 33	—	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 35100 and 35300.	—	—	—	32760 ng*hr/mL Geometric Coefficient of Variation 39	21620 ng*hr/mL Geometric Coefficient of Variation 30
AUCtau of Total Antibody Cycle 4 Day 1	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 398000.	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 265000.	—	—	—	NA ng*hr/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 61500 and 95900.	155800 ng*hr/mL Geometric Coefficient of Variation 62	—	—	—

SECONDARY outcome

Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Cmax of Total Antibody Cycle 1 Day 1	1475 ng/mL Geometric Coefficient of Variation 45	1622 ng/mL Geometric Coefficient of Variation 32	187.7 ng/mL Geometric Coefficient of Variation 23	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 240 and 424.	357.2 ng/mL Geometric Coefficient of Variation 20	482.9 ng/mL Geometric Coefficient of Variation 52	865.9 ng/mL Geometric Coefficient of Variation 32	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 2120 and 2860.	265.3 ng/mL Geometric Coefficient of Variation 27	209.1 ng/mL Geometric Coefficient of Variation 23
Cmax of Total Antibody Cycle 1 Day 15	—	—	282.7 ng/mL Geometric Coefficient of Variation 32	—	506.5 ng/mL Geometric Coefficient of Variation 44	—	—	—	305 ng/mL Geometric Coefficient of Variation 32	229.6 ng/mL Geometric Coefficient of Variation 25
Cmax of Total Antibody Cycle 4 Day 1	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 1170 and 1830.	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 1080 and 1320.	—	—	—	NA ng/mL Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 419 and 462.	813 ng/mL Geometric Coefficient of Variation 32	—	—	—

SECONDARY outcome

Tmax was determined directly from data as time of first occurrence. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Tmax of Total Antibody Cycle 4 Day 1	2.60 hr Interval 1.07 to 4.13	2.55 hr Interval 1.05 to 4.05	—	—	—	2.55 hr Interval 1.0 to 4.1	1.08 hr Interval 1.0 to 4.0	—	—	—
Tmax of Total Antibody Cycle 1 Day 1	1.05 hr Interval 1.05 to 4.05	1.08 hr Interval 1.0 to 4.0	1.00 hr Interval 1.0 to 4.0	1.00 hr Interval 1.0 to 1.0	1.00 hr Interval 1.0 to 4.0	1.00 hr Interval 1.0 to 1.05	1.00 hr Interval 0.85 to 4.0	3.81 hr Interval 3.62 to 4.0	1.00 hr Interval 1.0 to 4.0	1.00 hr Interval 1.0 to 4.0
Tmax of Total Antibody Cycle 1 Day 15	—	—	1.00 hr Interval 1.0 to 1.0	—	1.00 hr Interval 1.0 to 1.0	—	—	—	1.00 hr Interval 1.0 to 72.0	1.00 hr Interval 1.0 to 1.0

SECONDARY outcome

For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
CL of Total Antibody Cycle 4 Day 1	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 0.0113.	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 0.0155.	—	—	—	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 0.0276 and 0.0292.	0.02049 L/hr Geometric Coefficient of Variation 45	—	—	—
CL of Total Antibody Cycle 1 Day 1	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 0.0419.	0.03471 L/hr Geometric Coefficient of Variation 33	—	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 0.107.	—	0.04455 L/hr Geometric Coefficient of Variation 43	0.04947 L/hr Geometric Coefficient of Variation 17	—	—	—
CL of Total Antibody Cycle 1 Day 15	—	—	0.03736 L/hr Geometric Coefficient of Variation 35	—	NA L/hr Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 0.0312 and 0.0339.	—	—	—	0.03447 L/hr Geometric Coefficient of Variation 48	0.03411 L/hr Geometric Coefficient of Variation 5

SECONDARY outcome

Vss was determined by CL × MRT (mean residence time). MRT=\[AUMCtau +tau(AUCinf-AUCtau)\]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Vss of Total Antibody Cycle 1 Day 1	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 13.3.	8.074 L Geometric Coefficient of Variation 51	—	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 6.30.	—	10.32 L Geometric Coefficient of Variation 32	10.96 L Geometric Coefficient of Variation 17	—	—	—
Vss of Total Antibody Cycle 1 Day 15	—	—	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 5.09 and 6.45.	—	—	—	—	—	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values.. Individual values were 3.87 and 4.06.	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. Individual values were 4.82 and 5.19.
Vss of Total Antibody Cycle 4 Day 1	—	—	—	—	—	—	NA L Geometric Coefficient of Variation NA Individual values are reported when fewer than 3 participants had report able parameter values. The individual value was 5.33.	—	—	—

SECONDARY outcome

Timeframe: Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.

T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=2 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
t1/2 of Total Antibody Cycle 1 Day 1	—	—	7.860 day Standard Deviation 0.581	7.587 day Standard Deviation 2.34	NA day Standard Deviation NA Fewer than 3 subjects had reportable parameter values. The individual value was 10.1.	7.713 day Standard Deviation 1.52	—	—	—	NA day Standard Deviation NA Fewer than 3 subjects had reportable parameter values. The individual value was 1.88.
t1/2 of Total Antibody Cycle 4 Day 1	—	—	—	NA day Standard Deviation NA Fewer than 3 subjects had reportable parameter values. The individual value was 14.8.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Every Cycle: Days 1, 8, 15. up to end of treatment (Approximately 13 months)

Population: The analysis set was defined as enrolled patients who were analyzed for pharmacokinetics.

Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Cmax of Unconjugated Payload CL-184538	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).	NA ng/mL Geometric Coefficient of Variation NA CL-184538 (unconjugated payload) serum exposure was low with the majority of samples below the limit of quantitation (0.0500 ng/mL).

SECONDARY outcome

Timeframe: Baseline up to 7 days post end of treatment (Approximately 13 months)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.

Following parameters were analyzed for laboratory examination: hematology, blood chemistry, coagulation panel, urinalysis and pregnancy test.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	3 Participants	6 Participants	12 Participants	2 Participants	7 Participants	3 Participants	9 Participants	2 Participants	11 Participants	2 Participants

SECONDARY outcome

Timeframe: QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.

Positive was defined as: anti-drug antibody (ADA) titer \>=1.88. In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538) Positive Anti PF-06523432	0 Participants	0 Participants	3 Participants	—	0 Participants	0 Participants	0 Participants	—	1 Participants	0 Participants
Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538) Positive Anti-PF-06647263	1 Participants	1 Participants	5 Participants	0 Participants	4 Participants	2 Participants	4 Participants	0 Participants	8 Participants	2 Participants
Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538) Positive Anti CL-184538	1 Participants	0 Participants	5 Participants	—	2 Participants	2 Participants	4 Participants	—	6 Participants	2 Participants

SECONDARY outcome

Timeframe: QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.

Population: The analysis set included all participants who were treated and tested for that parameter.

Positive was defined as: neutralizing antibody titer \>=1.30. In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=1 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=1 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=5 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=4 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=4 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=8 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=2 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Positive Neutralizing Anti PF-06647263 Antibody	1 Participants	0 Participants	5 Participants	—	3 Participants	2 Participants	3 Participants	—	8 Participants	2 Participants

SECONDARY outcome

Timeframe: QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.

Treatment-Emergent=Baseline negative with at least one positive ADA sample post-treatment. Treatment-Boosted=Baseline positive but endpoint titer (log10-scale titer) increases by at least 0.5 (representing 3-fold titer increase). In time frame, C=cycle, D=day.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=3 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Number of Participants With Treatment-Emergent and Treatment-Boosted Anti PF-06647263 Antibody Treatment-emergent	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent and Treatment-Boosted Anti PF-06647263 Antibody Treatment-boosted	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Population: The analysis set included treated participants with measurable disease at baseline.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=11 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=1 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=6 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=7 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=2 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Percentage of Participants With Objective Response (Part 1)	66.7 Percentage of participants Interval 9.4 to 99.2	0 Percentage of participants Interval 0.0 to 45.9	9.1 Percentage of participants Interval 0.2 to 41.3	0 Percentage of participants Interval 0.0 to 97.5	16.7 Percentage of participants Interval 0.4 to 64.1	0 Percentage of participants Interval 0.0 to 70.8	14.3 Percentage of participants Interval 0.4 to 57.9	0 Percentage of participants Interval 0.0 to 84.2	—	0 Percentage of participants Interval 0.0 to 84.2

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Population: The analysis set included the number of participants with measurable disease at baseline.

Clinical Benefit Response (CBR) was defined as a CR, PR or stable disease (SD) ≥6 cycles. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as the reference of baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease: \>=20% increase in the sum of diameters of target lesions and an absolute increase of \>=5mm or appearance of \>=1 new lesion), taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=11 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=1 Participants Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=6 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=7 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) n=2 Participants Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Percentage of Participants With Clinical Benefit Response	66.7 Percentage of participants Interval 9.4 to 99.2	16.7 Percentage of participants Interval 0.4 to 64.1	36.4 Percentage of participants Interval 10.9 to 69.2	0 Percentage of participants Interval 0.0 to 97.5	16.7 Percentage of participants Interval 0.4 to 64.1	33.3 Percentage of participants Interval 0.8 to 90.6	42.9 Percentage of participants Interval 9.9 to 81.6	0 Percentage of participants Interval 0.0 to 84.2	25.0 Percentage of participants Interval 5.5 to 57.2	50.0 Percentage of participants Interval 1.3 to 98.7

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Population: The analysis set included the number of participants with event.

The progression free survival (PFS) was defined as the time from Cycle 1 Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. PFS was characterized by the estimate median time to event which was derived using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	PF-06647263 0.075 mg/kg Q3W (Part 1) n=1 Participants Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=8 Participants Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=4 Participants Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=2 Participants Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=4 Participants Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg Q3W (Part 1) n=1 Participants Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=8 Participants Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.	PF-06647263 0.01 mg/kg QW (Part 1) Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.
Progression Free Survival	NA month Interval 1.4 to With only one participant, we cannot calculate median or meaningful CI.	2.8 month Interval 0.6 to Only 33.3% (2/6) of the participants were with event. A 95% CI for the quantile is the set of all efficacy endpoint variable values satisfying the formula. In this group, only one variable value satisfied, so upper limit was not estimable.	3.0 month Interval 1.4 to 7.1	—	1.4 month Interval 0.6 to 8.3	5.3 month Interval 1.9 to 5.3	5.8 month Interval 1.9 to 7.3	NA month Interval 1.3 to With only one participant, we cannot calculate median or meaningful CI.	1.4 month Interval 0.7 to 3.0	—

SECONDARY outcome

Timeframe: Baseline up to 24 months

Population: OS was not estimable since there were fewer number of participants with event.

Outcome measures

Outcome data not reported

Adverse Events

PF-06647263 0.01 mg/kg QW (Part 1)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-06647263 0.015 mg/kg QW (Part 1)

Serious events: 6 serious events

Other events: 13 other events

Deaths: 4 deaths

PF-06647263 0.015 mg/kg Q3W (Part 1)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PF-06647263 0.02 mg/kg QW (Part 1)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-06647263 0.03 mg/kg Q3W (Part 1)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-06647263 0.05 mg/kg Q3W (Part 1)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

PF-06647263 0.075 mg/kg Q3W (Part 1)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-06647263 0.1 mg/kg Q3W (Part 1)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

PF-06647263 0.134 mg/kg QW (Part 1)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

PF-06647263 0.015 mg/kg QW (Part 2)

Serious events: 4 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	PF-06647263 0.01 mg/kg QW (Part 1) n=3 participants at risk Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 participants at risk Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 participants at risk Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 participants at risk Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 participants at risk Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 participants at risk Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 participants at risk Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 participants at risk Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg QW (Part 1) n=2 participants at risk Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 participants at risk Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastric fistula	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Death	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Disease progression	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Pyrexia	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Device related infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Sepsis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Influenza	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Other adverse events
Measure	PF-06647263 0.01 mg/kg QW (Part 1) n=3 participants at risk Participants received PF-06647263 0.01 mg/kg once weekly (QW) via intravenous (IV) infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 1) n=13 participants at risk Participants received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg Q3W (Part 1) n=2 participants at risk Participants received PF-06647263 0.015 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.02 mg/kg QW (Part 1) n=7 participants at risk Participants received PF-06647263 0.02 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.03 mg/kg Q3W (Part 1) n=3 participants at risk Participants received PF-06647263 0.03 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.05 mg/kg Q3W (Part 1) n=9 participants at risk Participants received PF-06647263 0.05 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.075 mg/kg Q3W (Part 1) n=3 participants at risk Participants received PF-06647263 0.075 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.1 mg/kg Q3W (Part 1) n=6 participants at risk Participants received PF-06647263 0.1 mg/kg every 3 weeks (Q3W) via IV infusion from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.134 mg/kg QW (Part 1) n=2 participants at risk Participants received PF-06647263 0.134 mg/kg every 3 weeks (Q3W) from Cycle 1 Day 1 until disease progression, patient refusal, unacceptable toxicity occurred or the study was terminated.	PF-06647263 0.015 mg/kg QW (Part 2) n=12 participants at risk Participants with triple negative breast cancer (TNBC) regardless of ephrin-A4 (EFNA4) were enrolled in Part 2 of the study when maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) was determined. They received PF-06647263 0.015 mg/kg once weekly (QW) via IV infusion from Cycle 1 Day 1 to the day that the decision was made to discontinue the participants from the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 2/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Splenic infarction	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	30.8% 4/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	42.9% 3/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 3/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 3/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	25.0% 3/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Palpitations	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Tachycardia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Dry eye	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Eye discharge	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Eye haemorrhage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Eye irritation	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Eye pruritus	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Eye symptom	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Iritis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Lacrimation increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Mydriasis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Ocular hyperaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Vision blurred	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Vitreous floaters	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 3/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 3/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain upper	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal rigidity	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Aphthous ulcer	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Ascites	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Buccal mucosal roughening	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Constipation	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	38.5% 5/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 3/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	25.0% 3/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	100.0% 3/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	57.1% 4/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 2/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	25.0% 3/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 2/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Flatulence	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gingival discolouration	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gingival disorder	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	69.2% 9/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	57.1% 4/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 3/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	44.4% 4/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 3/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 3/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 6/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Proctitis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Stomatitis	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 3/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Tongue coated	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Tongue discolouration	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Tongue ulceration	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	53.8% 7/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	57.1% 4/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 2/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 6/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Application site erosion	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Asthenia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 4/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Catheter site erythema	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Catheter site pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Catheter site related reaction	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Chest discomfort	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Chills	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Early satiety	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Face oedema	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Fatigue	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	76.9% 10/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	71.4% 5/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 6/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 3/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 4/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	41.7% 5/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Gait disturbance	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Generalised oedema	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Malaise	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Mucosal inflammation	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	38.5% 5/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	42.9% 3/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 2/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	58.3% 7/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Non-cardiac chest pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Oedema	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Oedema peripheral	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	30.8% 4/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 3/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	25.0% 3/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Pyrexia	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Temperature intolerance	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Hepatic congestion	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Hepatic fibrosis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Venoocclusive liver disease	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Immune system disorders Seasonal allergy	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Angular cheilitis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Candida infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Conjunctivitis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Device related infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Fungal infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Fungal skin infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Genital infection fungal	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Infected dermal cyst	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Oral candidiasis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Oral fungal infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Pneumonia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Rash pustular	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Rhinitis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Urinary tract infection	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Vaginal infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fracture	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Blood albumin decreased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Blood bilirubin increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Blood creatinine increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Breath sounds abnormal	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Cardiac murmur	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Electrocardiogram abnormal	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations International normalised ratio increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Neutrophil count decreased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Peritoneal fluid analysis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Platelet count decreased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Transaminases increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Weight decreased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	46.2% 6/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	57.1% 4/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	44.4% 4/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 3/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 4/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	41.7% 5/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	30.8% 4/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Marasmus	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	25.0% 3/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Ageusia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Cognitive disorder	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Disturbance in attention	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dizziness	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 2/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dizziness postural	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dysgeusia	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	46.2% 6/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 4/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Encephalopathy	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Headache	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Memory impairment	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Neuralgia	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Parosmia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Presyncope	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Somnolence	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Tremor	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Vocal cord paralysis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Agitation	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Anxiety	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Confusional state	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Depression	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Insomnia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Mental status changes	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Mood altered	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Bladder pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Chronic kidney disease	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Dysuria	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Haematuria	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Pelvic fluid collection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Perineal pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Vaginal discharge	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Vulvovaginal inflammation	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Vulvovaginal pruritus	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Vulvovaginal rash	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	38.5% 5/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 2/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	66.7% 2/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	25.0% 3/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Madarosis	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Nail bed tenderness	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 2/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Night sweats	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Onychalgia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Papule	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Photosensitivity reaction	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pigmentation disorder	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	25.0% 3/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 3/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	15.4% 2/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	28.6% 2/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin fragility	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	50.0% 1/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	14.3% 1/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	22.2% 2/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	100.0% 2/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin lesion	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Telangiectasia	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Urticaria	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	11.1% 1/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Aortic stenosis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 1/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Haemorrhage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypertension	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypotension	33.3% 1/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	23.1% 3/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Pallor	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.7% 1/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Cataract	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Eye disorders Diplopia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Axillary pain	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 2/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Feeling abnormal	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Localised oedema	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Bronchitis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Nail infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Weight increased	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Migraine	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Wound drainage	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hot flush	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/13 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/7 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/9 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/3 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/6 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/2 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 1/12 • Baseline up to 28 days after the last treatment administration (Approximately 13 months) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Additional Information

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Phone: 1-800-718-1021

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Results disclosure agreements

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

Restriction type: OTHER