Trial Outcomes & Findings for A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma (NCT NCT02570308)

Last Updated: 2023-03-21

Results Overview

Number of participants with a dose limiting toxicity, defined as an adverse event (AE) or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment and meets any of the pre-specified criteria.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

146 participants

Primary outcome timeframe

Up to 49 months

Results posted on

2023-03-21

Participant Flow

Of the 169 participants screened, 146 participants met the inclusion/exclusion criteria and were enrolled across 26 study centers in 5 countries.

The data cut-off date for this analysis was on 20 Mar 2020. The first patient was enrolled on 29 Feb 2016 in the Phase 1 dose escalation cohorts and on 19 Jan 2017 in the Phase 2 dose expansion cohort.

Participant milestones

Participant milestones
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
Overall Study STARTED	3	6	4	6	127
Overall Study COMPLETED	2	1	0	2	53
Overall Study NOT COMPLETED	1	5	4	4	74

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
Overall Study Death	1	5	4	4	69
Overall Study Lost to Follow-up	0	0	0	0	2
Overall Study Withdrawal by Subject	0	0	0	0	1
Overall Study Other	0	0	0	0	2

Baseline Characteristics

A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion: 68 mcg Tebentafusp n=127 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Total n=146 Participants Total of all reporting groups
Age, Continuous	61.3 Years STANDARD_DEVIATION 6.03 • n=5 Participants	54.7 Years STANDARD_DEVIATION 11.99 • n=7 Participants	56.5 Years STANDARD_DEVIATION 18.41 • n=5 Participants	55.8 Years STANDARD_DEVIATION 9.24 • n=4 Participants	61.0 Years STANDARD_DEVIATION 10.93 • n=21 Participants	60.4 Years STANDARD_DEVIATION 11.05 • n=10 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	64 Participants n=21 Participants	74 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	63 Participants n=21 Participants	72 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	126 Participants n=21 Participants	145 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 49 months

Population: The Safety Analysis Set (SAS) included all participants who received at least 1 full or partial dose of tebentafusp.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1	0 Participants	1 Participants	2 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Up to 38 months

Population: The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp.

Objective response rate (ORR) is defined as the percentage of participants with measurable disease with at least 1 visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an independent central review (ICR). The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=127 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Objective Response Rate in Phase 2	4.7 Percentage of participants Interval 1.8 to 10.0	—	—	—	—

SECONDARY outcome

Timeframe: Up to 49 months

Population: The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.

ORR is defined as the percentage of participants with measurable disease with at least 1 visit response of CR or PR that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an investigator. The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=19 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Objective Response Rate in Phase 1	15.8 Percentage of participants Interval 3.4 to 39.6	—	—	—	—

SECONDARY outcome

Timeframe: Up to 49 months

Progression-free survival is defined as the time in months from first dose of study drug until the date of disease progression or death (by any cause in the absence of disease progression) as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=19 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=127 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Progression-free Survival	7.4 Months Interval 1.2 to 14.8	2.8 Months Interval 2.0 to 3.7	—	—	—

SECONDARY outcome

Timeframe: 24 weeks

Disease control rate (DCR) is defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD) recorded at least 24 weeks (± 1 week) after commencement of study drug and prior to any progressive disease (PD) event, as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=19 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=127 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Disease Control Rate	47.4 Percentage of participants Interval 24.4 to 71.1	22.8 Percentage of participants Interval 15.9 to 31.1	—	—	—

SECONDARY outcome

Timeframe: Up to 49 months

Population: The analysis population included all participants who received at least 1 full or partial dose of tebentafusp and who achieved a response. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.

Duration of response (DOR) is defined as the time in months from the date of first documented objective response (CR or PR) until the date of documented disease progression or death by any cause in the absence of disease progression as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Duration of Response	7.425 Months Interval 3.713 to Not calculable because an insufficient number of participants reached the event at the final time point for assessment	8.706 Months Interval 5.552 to 24.542	—	—	—

SECONDARY outcome

Timeframe: Up to 49 months

Time to response (TTR) is defined as the time in months from the date of first dose of study drug until the date of first documented objective response as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Time to Response	5.5 Months Standard Deviation 1.8	7.0 Months Standard Deviation 6.9	—	—	—

SECONDARY outcome

Timeframe: Up to 49 months

Overall survival (OS) is defined as the time in months from the date of first dose of study drug until death due to any cause in general.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=19 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=127 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Overall Survival	29.6 Months Interval 10.9 to 42.2	16.8 Months Interval 12.9 to 21.3	—	—	—

SECONDARY outcome

Timeframe: Up to 49 months

Rate of minor response (or better) is defined as the proportion of participants with a confirmed CR, PR, or minor response (MinR) as assessed by RECIST v1.1 by the investigator for Phase 1 or ICR for Phase 2, where MinR is a reduction from baseline in sum of diameters between 10%-29%. The sum of diameters is defined as per RECIST v1.1 as the sum of longest diameters or short axis of target lesions (mm).

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=19 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=127 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Minor Response Rate	26.3 Percentage of participants Interval 9.1 to 51.2	11.0 Percentage of participants Interval 6.2 to 17.8	—	—	—

SECONDARY outcome

Timeframe: Up to 49 months

Population: The Safety Analysis Set (SAS) included all participants who received at least 1 full or partial dose of tebentafusp.

Tolerability of study treatment was assessed by summarizing the number of participants with dose interruptions or reductions that occurred during the treatment period.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion n=127 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Number of Participants With Treatment Dose Interruptions or Reductions	2 Participants	4 Participants	3 Participants	4 Participants	49 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose

Population: All participants who received at least 1 full or partial dose of tebentafusp and with detectable serum concentrations are included.

The AUC was determined in in dose escalation cohorts.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Area Under the Plasma Concentration-Time Curve (AUC) of Tebentafusp Cycle 1 Day 1	28550 hr*pg/mL Standard Deviation 27.0	36530 hr*pg/mL Standard Deviation 23.3	32920 hr*pg/mL Standard Deviation 18.2	33030 hr*pg/mL Standard Deviation 16.5	—
Area Under the Plasma Concentration-Time Curve (AUC) of Tebentafusp Cycle 1 Day 15	81310 hr*pg/mL Standard Deviation 33.7	98660 hr*pg/mL Standard Deviation 34.8	106800 hr*pg/mL Standard Deviation 11.6	109800 hr*pg/mL Standard Deviation 23.3	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose

Population: All participants who received at least 1 full or partial dose of tebentafusp and with detectable serum concentrations are included.

The Cmax is determined in dose escalation cohorts.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Maximum Plasma Concentration (Cmax) of Tebentafusp Cycle 1 Day 1	3050 pg/mL Standard Deviation 15.1	3294 pg/mL Standard Deviation 22.7	3041 pg/mL Standard Deviation 21.7	3640 pg/mL Standard Deviation 23.3	—
Maximum Plasma Concentration (Cmax) of Tebentafusp Cycle 1 Day 15	8885 pg/mL Standard Deviation 17.2	9523 pg/mL Standard Deviation 23.0	11300 pg/mL Standard Deviation 11.7	11520 pg/mL Standard Deviation 25.8	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose

Population: All participants who received at least 1 full or partial dose of tebentafusp and with detectable serum concentrations are included.

The Tmax of tebentafusp is determined in dose escalation cohorts.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Time to Maximum Plasma Concentration (Tmax) of Tebentafusp Cycle 1 Day 1	0.50 Hours Interval 0.5 to 0.5	0.50 Hours Interval 0.5 to 0.5	0.50 Hours Interval 0.5 to 0.5	0.50 Hours Interval 0.5 to 0.5	—
Time to Maximum Plasma Concentration (Tmax) of Tebentafusp Cycle 1 Day 15	0.50 Hours Interval 0.5 to 0.5	0.50 Hours Interval 0.5 to 0.5	0.50 Hours Interval 0.5 to 0.5	0.50 Hours Interval 0.5 to 0.5	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose

Population: All participants who received at least 1 full or partial dose of tebentafusp and with detectable serum concentrations are included.

The t½ of tebentafusp is reported in dose escalation cohorts.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Apparent Terminal Plasma Half-life (t½) of Tebentafusp Cycle 1 Day 1	6.635 Hours Interval 5.4 to 6.67	7.591 Hours Interval 6.03 to 11.3	6.442 Hours Interval 5.82 to 7.63	6.273 Hours Interval 5.59 to 10.1	—
Apparent Terminal Plasma Half-life (t½) of Tebentafusp Cycle 1 Day 15	6.897 Hours Interval 6.78 to 8.03	7.532 Hours Interval 6.57 to 10.5	7.519 Hours Interval 6.36 to 9.24	7.488 Hours Interval 5.7 to 11.9	—

SECONDARY outcome

Timeframe: Up to 49 months

Population: The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp and with evaluable data; two participants were excluded from ADA evaluation due to lack of sampling after dosing.

Overall antidrug antibody (ADA) is presented as number of ADA-positive participants relative to total number of participants with evaluable ADA results in each cohort

Outcome measures

Outcome measures
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion n=125 Participants Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).
Percentage of Participants With Anti-IMCgp100 Antibody Formation	66.7 Percentage of participants	16.7 Percentage of participants	25.0 Percentage of participants	33.3 Percentage of participants	33.6 Percentage of participants

Adverse Events

Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp

Serious events: 2 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp

Serious events: 3 serious events

Other events: 4 other events

Deaths: 4 deaths

Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp

Serious events: 3 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 2 Dose Expansion: 68 mcg Tebentafusp

Serious events: 42 serious events

Other events: 127 other events

Deaths: 69 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion: 68 mcg Tebentafusp n=127 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
General disorders Pyrexia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.1% 9/127 • Number of events 11 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Infusion-related reaction	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Atrial flutter	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Cardiac failure	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Left ventricular dysfunction	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Nausea	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Multiple organ system dysfunction syndrome	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Hepatobiliary disorders Biliary colic	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Sepsis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Anal abscess	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Arthritis infective	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Biliary tract infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Device related infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Lung infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations General physical condition decreased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Platelet count decreased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Spinal cord compression	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Aphasia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Hemorrhage intracranial	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Psychiatric disorders Confusional state	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash generalized	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Embolism	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Hypertensive crisis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Infarction	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.

Other adverse events

Other adverse events
Measure	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp n=3 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp n=6 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp n=4 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp n=6 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	Phase 2 Dose Expansion: 68 mcg Tebentafusp n=127 participants at risk Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Ear and labyrinth disorders Vertigo	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Eye disorders Dry eye	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.1% 9/127 • Number of events 12 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Eye disorders Eye inflammation	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Eye disorders Eyelash hypopigmentation	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Eye disorders Lacrimation increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Eye disorders Ocular hyperemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Eye disorders Periorbital edema	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	26.8% 34/127 • Number of events 69 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Eye disorders Vision blurred	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	4.7% 6/127 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Eye disorders Visual impairment	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	11.0% 14/127 • Number of events 16 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	35.4% 45/127 • Number of events 71 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Abdominal pain upper	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	20.5% 26/127 • Number of events 38 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	23.6% 30/127 • Number of events 45 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Dental caries	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 11 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	26.0% 33/127 • Number of events 50 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	11.8% 15/127 • Number of events 21 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Eructation	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	4.7% 6/127 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Localized infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Nail infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Nasopharyngitis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	10.2% 13/127 • Number of events 18 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Oral herpes	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Otitis media	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Pharyngitis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Sinusitis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	5.5% 7/127 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Skin infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Tinea pedis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Tooth infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	12.6% 16/127 • Number of events 23 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 21 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 4/4 • Number of events 18 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 14 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	67.7% 86/127 • Number of events 247 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 11 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	40.9% 52/127 • Number of events 141 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Asthenia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.1% 9/127 • Number of events 20 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Chest pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Chills	66.7% 2/3 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 14 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 4/4 • Number of events 48 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 20 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.1% 84/127 • Number of events 282 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Face edema	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	11.8% 15/127 • Number of events 32 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Facial pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Fatigue	66.7% 2/3 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 16 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 4/4 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 6/6 • Number of events 21 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	61.4% 78/127 • Number of events 134 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Feeling hot	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Gait disturbance	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Generalized edema	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	6.3% 8/127 • Number of events 12 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Impaired healing	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Influenza like illness	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 21 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	18.1% 23/127 • Number of events 49 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Infusion site hematoma	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Malaise	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.1% 9/127 • Number of events 10 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Nodule	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Edema peripheral	100.0% 3/3 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 12 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	34.6% 44/127 • Number of events 86 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Peripheral swelling	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Pyrexia	100.0% 3/3 • Number of events 15 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 6/6 • Number of events 16 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 16 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 6/6 • Number of events 21 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	81.1% 103/127 • Number of events 417 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Temperature regulation disorder	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Hepatobiliary disorders Hepatic pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	5.5% 7/127 • Number of events 10 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Hyperbilirubinemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.9% 10/127 • Number of events 16 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.9% 10/127 • Number of events 45 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Diverticulitis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Fungal skin infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Cardiac murmur	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Lipase increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	9.4% 12/127 • Number of events 19 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Weight decreased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	15.7% 20/127 • Number of events 20 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.9% 5/127 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
General disorders Pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.9% 10/127 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	5.5% 7/127 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Ligament injury	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	6.3% 8/127 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Scratch	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 11 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.9% 5/127 • Number of events 11 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Sunburn	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	15.0% 19/127 • Number of events 33 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Amylase increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	5.5% 7/127 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	18.1% 23/127 • Number of events 36 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Blood alklaline phosphatase increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	10.2% 13/127 • Number of events 19 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Blood cholesterol increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Investigations Blood creatinine increased	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	8.7% 11/127 • Number of events 16 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	12.6% 16/127 • Number of events 18 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Infections and infestations Wound infection	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.9% 10/127 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.9% 5/127 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	11.0% 14/127 • Number of events 24 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	10.2% 13/127 • Number of events 22 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	11.0% 14/127 • Number of events 25 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.2% 32/127 • Number of events 45 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.9% 5/127 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	26.0% 33/127 • Number of events 45 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Myalgia	100.0% 3/3 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	18.1% 23/127 • Number of events 33 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 19 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 10 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	15.0% 19/127 • Number of events 33 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 10 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	9.4% 12/127 • Number of events 23 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Back pain	66.7% 2/3 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 24 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 4/4 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	32.3% 41/127 • Number of events 57 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	8.7% 11/127 • Number of events 14 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	4.7% 6/127 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.9% 5/127 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 11 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Musculoskeletal and connective tissue disorders Pain in jaw	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Reproductive system and breast disorders Breast pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	22.8% 29/127 • Number of events 49 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	18.9% 24/127 • Number of events 34 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	10.2% 13/127 • Number of events 16 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.9% 10/127 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	5.5% 7/127 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Pruritus	100.0% 3/3 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 25 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 4/4 • Number of events 18 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	100.0% 6/6 • Number of events 26 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	68.5% 87/127 • Number of events 206 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	40.9% 52/127 • Number of events 68 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	40.2% 51/127 • Number of events 121 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.1% 42/127 • Number of events 88 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Hair color changes	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	26.8% 34/127 • Number of events 38 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 20 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 19 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	17.3% 22/127 • Number of events 33 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash generalized	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	23.6% 30/127 • Number of events 63 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	19.7% 25/127 • Number of events 31 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.5% 21/127 • Number of events 22 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Generalized erythema	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	15.7% 20/127 • Number of events 59 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Pruritus generalized	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	17.3% 22/127 • Number of events 70 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	9.4% 12/127 • Number of events 12 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Skin mass	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 11 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	8.7% 11/127 • Number of events 15 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Night sweats	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	8.7% 11/127 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	6.3% 8/127 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash erythematous	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	4.7% 6/127 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 12 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.9% 5/127 • Number of events 18 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	5.5% 7/127 • Number of events 7 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash macular	33.3% 1/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 15 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	4.7% 6/127 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Blister	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	22.0% 28/127 • Number of events 32 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Ephelides	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Papule	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Scab	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Miiaria	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Nail discoloration	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Purpura	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Sensitive skin	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Hypotension	100.0% 3/3 • Number of events 8 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 5 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	83.3% 5/6 • Number of events 10 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	41.7% 53/127 • Number of events 115 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Hypertension	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	14.2% 18/127 • Number of events 53 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Hot flush	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	11.0% 14/127 • Number of events 26 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Vascular disorders Flushing	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	12.6% 16/127 • Number of events 20 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Syncope	66.7% 2/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Neuropathy peripheral	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Aphasia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Ataxia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Cerebral arteriosclerosis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Disturbance in attention	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Psychiatric disorders Insomnia	66.7% 2/3 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	15.7% 20/127 • Number of events 23 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Psychiatric disorders Anxiety	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	10.2% 13/127 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Psychiatric disorders Confusional state	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	6.3% 8/127 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Psychiatric disorders Depression	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	4.7% 6/127 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Psychiatric disorders Depressed mood	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Renal and urinary disorders Dysuria	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	2.4% 3/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Renal and urinary disorders Chromaturia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	33.3% 1/3 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	6.3% 8/127 • Number of events 11 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Renal and urinary disorders Nocturia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor inflammation	33.3% 1/3 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Headache	66.7% 2/3 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	66.7% 4/6 • Number of events 12 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.1% 42/127 • Number of events 91 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 3/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.5% 21/127 • Number of events 25 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Paresthesia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	7.9% 10/127 • Number of events 15 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	9.4% 12/127 • Number of events 13 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	50.0% 2/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	5.5% 7/127 • Number of events 9 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Nervous system disorders Memory impairment	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	75.0% 3/4 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	33.3% 2/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	13.4% 17/127 • Number of events 21 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	3.1% 4/127 • Number of events 4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Cardiomegaly	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Hypertensive heart disease	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Palpitations	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	1.6% 2/127 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Pericardial effusion	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	9.4% 12/127 • Number of events 15 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Cardiac disorders Tachycardia	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	11.8% 15/127 • Number of events 22 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Ear and labyrinth disorders Ear discomfort	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 2 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.79% 1/127 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Ear and labyrinth disorders Hyperacusis	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	16.7% 1/6 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Ear and labyrinth disorders Otorrhea	0.00% 0/3 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	25.0% 1/4 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.
Ear and labyrinth disorders Parasthesia ear	33.3% 1/3 • Number of events 1 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/4 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/6 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.	0.00% 0/127 • Up to 49 months Adverse events (AEs) are defined as treatment-emergent AEs that started or worsened after the first dose of study drug and within 90 days after the last dose.

Additional Information

Nicola McKelvie

Immunocore, Ltd

Phone: 484-534-5261

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place