Trial Outcomes & Findings for Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor (NCT NCT02471716)

Last Updated: 2021-08-31

Results Overview

Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

66 participants

Primary outcome timeframe

52 weeks

Results posted on

2021-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Overall Study STARTED	3	3	3	33	24
Overall Study COMPLETED	3	2	3	18	8
Overall Study NOT COMPLETED	0	1	0	15	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Overall Study Withdrawal by Subject	1	2	5
Overall Study Study Terminiated by sponsor	0	1	0
Overall Study Lost to Follow-up	0	3	2
Overall Study Death	0	1	0
Overall Study Other	0	8	9

Baseline Characteristics

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=3 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=33 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=24 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.	Total n=66 Participants Total of all reporting groups
Race/Ethnicity, Customized White	3 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	9 Participants n=483 Participants	9 Participants n=36 Participants	25 Participants n=10 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	32 Participants n=483 Participants	22 Participants n=36 Participants	62 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants	4 Participants n=10 Participants
Age, Continuous	37.7 years STANDARD_DEVIATION 11.24 • n=93 Participants	40.7 years STANDARD_DEVIATION 23.07 • n=4 Participants	41.7 years STANDARD_DEVIATION 7.51 • n=27 Participants	38 years STANDARD_DEVIATION 12.77 • n=483 Participants	44.1 years STANDARD_DEVIATION 15.32 • n=36 Participants	40.8 years STANDARD_DEVIATION 14.03 • n=10 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	23 Participants n=483 Participants	10 Participants n=36 Participants	40 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	10 Participants n=483 Participants	14 Participants n=36 Participants	26 Participants n=10 Participants
Race/Ethnicity, Customized American Indian/alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized Black	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants	2 Participants n=10 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants	1 Participants n=36 Participants	7 Participants n=10 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	19 Participants n=483 Participants	8 Participants n=36 Participants	27 Participants n=10 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	4 Participants n=36 Participants	5 Participants n=10 Participants

PRIMARY outcome

Timeframe: 52 weeks

Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=3 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: 52 weeks

Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2)

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=32 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=24 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2)	8 Participants	8 Participants	—	—	—

SECONDARY outcome

Timeframe: 52 weeks

Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=2 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=1 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=2 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=3 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC)	102 ug x day/mL Geometric Coefficient of Variation 10.2	283 ug x day/mL Geometric Coefficient of Variation 26.3	593 ug x day/mL Geometric Coefficient of Variation 31.3	660 ug x day/mL Geometric Coefficient of Variation 17.7	593 ug x day/mL Geometric Coefficient of Variation 12.6

SECONDARY outcome

Timeframe: 52 weeks

Composite PK parameters of cabiralizumab: Maximum observed serum concentration

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=3 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=30 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=24 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Maximum Serum Concentration (Cmax).	22.5 ug/mL Geometric Coefficient of Variation 14.3	52.1 ug/mL Geometric Coefficient of Variation 22	91.2 ug/mL Geometric Coefficient of Variation 15	91.8 ug/mL Geometric Coefficient of Variation 24.8	87 ug/mL Geometric Coefficient of Variation 12.6

SECONDARY outcome

Timeframe: 52 weeks

Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin).

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=3 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=30 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=24 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Minimum Serum Concentration (Cmin).	2.18 ug/mL Geometric Coefficient of Variation 117	7.26 ug/mL Geometric Coefficient of Variation 41.8	21.2 ug/mL Geometric Coefficient of Variation 59.2	23.9 ug/mL Geometric Coefficient of Variation 38.3	22.6 ug/mL Geometric Coefficient of Variation 28.2

SECONDARY outcome

Timeframe: 52 weeks

Composite PK parameters of cabiralizumab: clearance (CL)

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=2 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=1 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=2 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=3 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Pharmacokinetic Clearance (CL).	.663 L/d Geometric Coefficient of Variation 16.6	.416 L/d Geometric Coefficient of Variation 24.5	.694 L/d Geometric Coefficient of Variation 0	.307 L/d Geometric Coefficient of Variation 44.9	.525 L/d Geometric Coefficient of Variation 8.42

SECONDARY outcome

Timeframe: 52 weeks

treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE.

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=3 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=33 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=24 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
The Incidence of AEs.	3 Participants	3 Participants	3 Participants	33 Participants	24 Participants

SECONDARY outcome

Timeframe: 52 weeks

The number of patients with a clinical laboratory that is outside the normal range at some time point during the study

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=2 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=33 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=24 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
The Incidence of Clinical Laboratory Abnormalities.	3 participants	2 participants	3 participants	33 participants	24 participants

SECONDARY outcome

Timeframe: 52 weeks

Population: The changes in the ECG parameters were not clinically significant in any dosing cohort in the study

The number of patients who had a change in their ECG that were clinically significant

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=3 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 Participants Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=33 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=24 Participants Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
The Incidence of ECG Abnormalities.	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 52 weeks

The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2

Outcome measures

Outcome measures
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=8 Participants Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=8 Participants Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Duration of Response Per RECIST 1.1 in Phase 2	4.4 months Interval 3.2 to the upper bound of the confidence interval was not reached	NA months Interval 11.5 to The median duration of response was not reached	—	—	—

Adverse Events

Phase 1 FPA008 Dose Escalation 1mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 FPA008 Dose Escalation 2mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 FPA008 Dose Escalation 4mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 2 FPA008 Dose Expansion Cohort 2A

Serious events: 8 serious events

Other events: 33 other events

Deaths: 1 deaths

Phase 2 FPA008 Dose Expansion Cohort 2B

Serious events: 6 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 participants at risk Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=3 participants at risk Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 participants at risk Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=33 participants at risk Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=24 participants at risk Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Colitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Diverticulum	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Pyrexia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Influenza like illness	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Systemic inflammatory response syndrome	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Lobar pneumonia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Viral infection	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Cerebellar infarction	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Migraine	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Congenital, familial and genetic disorders Twin reversed arterial perfusion sequence malformation	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Reproductive system and breast disorders Menorrhagia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Streptococcal sepsis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Intervertebral discitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Endocarditis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Cardiac disorders Myocarditis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Vascular disorders Hypertension	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.

Other adverse events

Other adverse events
Measure	Phase 1 FPA008 Dose Escalation 1mg/kg n=3 participants at risk Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 2mg/kg n=3 participants at risk Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks	Phase 1 FPA008 Dose Escalation 4mg/kg n=3 participants at risk Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks	Phase 2 FPA008 Dose Expansion Cohort 2A n=33 participants at risk Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.	Phase 2 FPA008 Dose Expansion Cohort 2B n=24 participants at risk Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Cardiac disorders Palpitations	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Ear and labyrinth disorders Hearing impaired	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Endocrine disorders Cushingoid	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Abnormal sensation in eye	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Conjunctival hyperaemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Conjunctival oedema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Dry eye	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Eye pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Eyelid oedema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	18.2% 6/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	29.2% 7/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Eyelid rash	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Eyelid skin dryness	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Lacrimation increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.1% 4/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	20.8% 5/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Periorbital oedema	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	60.6% 20/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	54.2% 13/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Photophobia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Scleritis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Vision blurred	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	20.8% 5/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Eye disorders Visual acuity reduced	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Colitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Constipation	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Food poisoning	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Lip swelling	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Nausea	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	15.2% 5/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.1% 4/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Abdominal discomfort	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Lip oedema	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Asthenia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	21.2% 7/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	20.8% 5/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Chest pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Chills	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Face oedema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 22/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	50.0% 12/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Fatigue	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	100.0% 3/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 11/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 8/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Gait disturbance	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Generalised oedema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Local swelling	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Non-cardiac chest pain	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Oedema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Oedema peripheral	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	57.6% 19/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 8/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Peripheral swelling	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Pyrexia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	15.2% 5/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Sensation of foreign body	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Swelling	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Hepatobiliary disorders Biliary colic	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Hepatobiliary disorders Hepatic pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Abscess	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Acarodermatitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Cellulitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Conjunctivitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Ear infection	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Gastroenteritis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Hordeolum	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Influenza	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Oral candidiasis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Otitis externa	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Pneumonia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Respiratory tract infection	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Urinary tract infection	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Viral infection	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
General disorders Localised oedema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Injury, poisoning and procedural complications Joint injury	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Injury, poisoning and procedural complications Post procedural inflammation	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	18.2% 6/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	30.3% 10/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Blood bilirubin increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Blood cholesterol increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.1% 4/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	100.0% 3/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	63.6% 21/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 16/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.1% 4/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Blood pressure increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations C-reactive protein increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Troponin I increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Investigations Weight increased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	21.2% 7/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Metabolism and nutrition disorders Increased appetite	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	30.3% 10/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of bone	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Burning sensation	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Dizziness	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Dysgeusia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Headache	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	21.2% 7/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Hyperaesthesia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Migraine	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Neuralgia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Nystagmus	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Paraesthesia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	15.2% 5/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Poor quality sleep	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Sciatica	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Nervous system disorders Tremor	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Psychiatric disorders Affective disorder	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Psychiatric disorders Anxiety	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Psychiatric disorders Insomnia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Renal and urinary disorders Bladder spasm	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Renal and urinary disorders Dysuria	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Renal and urinary disorders Haematuria	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Reproductive system and breast disorders Menorrhagia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.1% 4/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Dermatitis	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	16.7% 4/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	15.2% 5/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Generalised erythema	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Macule	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Mechanical urticaria	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	51.5% 17/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	54.2% 13/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Pruritus generalised	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	15.2% 5/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 11/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	41.7% 10/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	24.2% 8/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Rash pruritic	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	15.2% 5/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	66.7% 2/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.1% 4/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	20.8% 5/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	8.3% 2/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	4.2% 1/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Skin striae	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	33.3% 1/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	9.1% 3/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	3.0% 1/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
Vascular disorders Hypertension	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	0.00% 0/3 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	6.1% 2/33 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.	12.5% 3/24 • Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.

Additional Information

Medical

FivePrime Theraputics

Phone: 415-365-5600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place