Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629) (NCT NCT03284424)

NCT ID: NCT03284424

Last Updated: 2024-08-23

Results Overview

ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 159 participants
• Primary outcome timeframe: Up to approximately 32 months
• Results posted on: 2024-08-23

Participant Flow

There were 2 cohorts in this study and each cohort received the same dose/treatment regimen. Participant flow, baseline characteristics, and outcome measures are presented by cohort. Adverse events were pre-specified to be reported as a single group by intervention for first and second course pembrolizumab.

Participant milestones

Measure	Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Locally Advanced Unresectable cSCC Cohort Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Overall Study STARTED	105	54
Overall Study Participants That Received a Second Course of Pembrolizumab	2	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	105	54

Reasons for withdrawal

Measure	Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Locally Advanced Unresectable cSCC Cohort Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Overall Study Death	70	24
Overall Study Lost to Follow-up	3	1
Overall Study Physician Decision	1	2
Overall Study Withdrawal by Subject	4	5
Overall Study Sponsor's decision	27	22

Baseline Characteristics

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)

Baseline characteristics by cohort

Measure	Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort n=105 Participants Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Locally Advanced Unresectable cSCC Cohort n=54 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Total n=159 Participants Total of all reporting groups
Age, Continuous	70.0 Years STANDARD_DEVIATION 14.3 • n=5 Participants	73.7 Years STANDARD_DEVIATION 12.4 • n=7 Participants	71.3 Years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	39 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	40 Participants n=7 Participants	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	35 Participants n=5 Participants	12 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	40 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants	12 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 32 months

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) is presented.

Outcome measures

Measure	Recurrent or Metastatic Cutaneous cSCC Cohort n=105 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Locally Advanced Unresectable cSCC Cohort n=54 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
Objective Response Rate (ORR)	35.2 Percentage of participants Interval 26.2 to 45.2	51.9 Percentage of participants Interval 37.8 to 65.7

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment and had confirmed complete response or partial response.

For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 as assessed by BICR is presented for all participants who experienced a confirmed CR or PR.

Outcome measures

Measure	Recurrent or Metastatic Cutaneous cSCC Cohort n=37 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Locally Advanced Unresectable cSCC Cohort n=28 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
Duration of Response (DOR)	1.6 Months Interval 1.2 to 24.7	2.7 Months Interval 1.1 to 12.3

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

DCR is defined as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease). The DCR per RECIST 1.1 as assessed by BICR is presented.

Outcome measures

Measure	Recurrent or Metastatic Cutaneous cSCC Cohort n=105 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Locally Advanced Unresectable cSCC Cohort n=54 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
Disease Control Rate (DCR)	52.4 Percentage of participants Interval 42.4 to 62.2	64.8 Percentage of participants Interval 50.6 to 77.3

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause, whichever occurred first. PFS per RECIST 1.1 as assessed by BICR is presented.

Outcome measures

Measure	Recurrent or Metastatic Cutaneous cSCC Cohort n=105 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Locally Advanced Unresectable cSCC Cohort n=54 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
Progression-free Survival (PFS)	5.7 Months Interval 3.1 to 8.5	14.4 Months Interval 5.5 to 43.6

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

OS was defined as the time from first dose of study treatment to death due to any cause. The OS for all participants is presented.

Outcome measures

Measure	Recurrent or Metastatic Cutaneous cSCC Cohort n=105 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Locally Advanced Unresectable cSCC Cohort n=54 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
Overall Survival (OS)	23.8 Months Interval 13.4 to 30.9	NA Months Interval 33.3 to NA= Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who experienced an AE is presented.

Outcome measures

Measure	Recurrent or Metastatic Cutaneous cSCC Cohort n=105 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Locally Advanced Unresectable cSCC Cohort n=54 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
Number of Participants Who Experienced One or More Adverse Events (AEs)	102 Participants	51 Participants

SECONDARY outcome

Timeframe: Up to approximately 56 months

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who discontinued study treatment due to an AE is presented.

Outcome measures

Measure	Recurrent or Metastatic Cutaneous cSCC Cohort n=105 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Locally Advanced Unresectable cSCC Cohort n=54 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
Number of Participants Who Discontinued Study Treatment Due to AE	20 Participants	11 Participants

Adverse Events

Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course

Serious events: 87 serious events

Other events: 139 other events

Deaths: 97 deaths

Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course n=159 participants at risk Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course n=3 participants at risk Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Blood and lymphatic system disorders Anaemia	1.9% 3/159 • Number of events 3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Blood and lymphatic system disorders Haemolytic anaemia	0.63% 1/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Blood and lymphatic system disorders Lymphadenopathy	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Cardiac disorders Acute myocardial infarction	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Cardiac disorders Angina pectoris	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Cardiac disorders Atrial fibrillation	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Cardiac disorders Cardiac failure	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Cardiac disorders Cardiac failure chronic	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Cardiac disorders Coronary artery disease	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Cardiac disorders Myocardial infarction	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Cardiac disorders Ventricular extrasystoles	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Endocrine disorders Adrenal insufficiency	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Endocrine disorders Lymphocytic hypophysitis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Abdominal pain lower	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Abdominal wall haemorrhage	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Colitis	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Constipation	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Diverticulum	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Duodenal ulcer perforation	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Dysphagia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Large intestine perforation	1.3% 2/159 • Number of events 3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Nausea	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Oral pain	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Vomiting	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders Asthenia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders Death	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders General physical health deterioration	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders Pyrexia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Hepatobiliary disorders Autoimmune hepatitis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/159 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Hepatobiliary disorders Hypertransaminasaemia	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Immune system disorders Anaphylactic reaction	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Abscess neck	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Appendicitis perforated	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Arthritis bacterial	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Bacteraemia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations COVID-19	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Cellulitis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Clostridium difficile infection	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Dermo-hypodermitis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Device related infection	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Device related sepsis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Fungal skin infection	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Gastroenteritis salmonella	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Infestation	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Liver abscess	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Lower respiratory tract infection	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Oral candidiasis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Otitis externa	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Pneumonia	3.1% 5/159 • Number of events 5 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Pneumonia aspiration	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Respiratory tract infection	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Scrotal cellulitis	0.00% 0/159 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Sepsis	2.5% 4/159 • Number of events 4 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Septic shock	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Soft tissue infection	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Staphylococcal infection	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Subcutaneous abscess	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Urinary tract infection	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Wound infection	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Fall	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Femur fracture	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Head injury	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Hip fracture	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Infusion related reaction	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Joint injury	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Osteoradionecrosis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Radiation necrosis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Subdural haematoma	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Toxicity to various agents	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Wound complication	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Blood creatinine increased	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Transaminases increased	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Weight decreased	0.00% 0/159 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.63% 1/159 • Number of events 3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Metabolism and nutrition disorders Hyponatraemia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Metabolism and nutrition disorders Hypophagia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Back pain	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Groin pain	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Pain in extremity	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	5.7% 9/159 • Number of events 19 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	1.9% 3/159 • Number of events 3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm recurrence	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Cerebrospinal fluid leakage	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Cranial nerve disorder	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Dementia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Epilepsy	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Neuropathy peripheral	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Peripheral sensory neuropathy	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Transient ischaemic attack	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Renal and urinary disorders Acute kidney injury	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Renal and urinary disorders Autoimmune nephritis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Renal and urinary disorders Nephrolithiasis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Renal and urinary disorders Prerenal failure	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Renal and urinary disorders Urinary retention	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.63% 1/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.63% 1/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Skin and subcutaneous tissue disorders Rash	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Vascular disorders Giant cell arteritis	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Vascular disorders Peripheral ischaemia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Vascular disorders Superior vena cava occlusion	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.

Other adverse events

Measure	Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course n=159 participants at risk Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).	Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course n=3 participants at risk Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Skin and subcutaneous tissue disorders Actinic keratosis	5.7% 9/159 • Number of events 15 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Skin and subcutaneous tissue disorders Dry skin	6.9% 11/159 • Number of events 11 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Blood and lymphatic system disorders Anaemia	11.3% 18/159 • Number of events 26 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Endocrine disorders Hypothyroidism	8.8% 14/159 • Number of events 16 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Abdominal pain	8.2% 13/159 • Number of events 14 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Constipation	25.2% 40/159 • Number of events 47 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Diarrhoea	19.5% 31/159 • Number of events 38 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Nausea	14.5% 23/159 • Number of events 29 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Gastrointestinal disorders Vomiting	10.1% 16/159 • Number of events 22 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders Asthenia	22.0% 35/159 • Number of events 44 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders Chest pain	5.0% 8/159 • Number of events 8 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders Fatigue	22.0% 35/159 • Number of events 39 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders Oedema peripheral	10.7% 17/159 • Number of events 21 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
General disorders Pyrexia	8.8% 14/159 • Number of events 17 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Bronchitis	5.0% 8/159 • Number of events 8 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Infections and infestations Urinary tract infection	5.0% 8/159 • Number of events 10 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Injury, poisoning and procedural complications Fall	6.9% 11/159 • Number of events 13 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Blood bilirubin increased	1.9% 3/159 • Number of events 4 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Blood creatinine increased	5.0% 8/159 • Number of events 8 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Blood phosphorus decreased	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Blood urea increased	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Protein total decreased	0.63% 1/159 • Number of events 7 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Investigations Weight decreased	11.3% 18/159 • Number of events 19 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Metabolism and nutrition disorders Decreased appetite	15.7% 25/159 • Number of events 27 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Metabolism and nutrition disorders Hypercalcaemia	5.0% 8/159 • Number of events 10 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Metabolism and nutrition disorders Hyperchloraemia	0.63% 1/159 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Metabolism and nutrition disorders Hypocalcaemia	2.5% 4/159 • Number of events 4 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Metabolism and nutrition disorders Hyponatraemia	2.5% 4/159 • Number of events 7 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	13.8% 22/159 • Number of events 26 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Back pain	8.8% 14/159 • Number of events 15 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Muscle spasms	1.3% 2/159 • Number of events 2 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Neck pain	5.0% 8/159 • Number of events 8 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Musculoskeletal and connective tissue disorders Pain in extremity	16.4% 26/159 • Number of events 29 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Dizziness	6.9% 11/159 • Number of events 12 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Headache	11.3% 18/159 • Number of events 20 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Nervous system disorders Paraesthesia	3.8% 6/159 • Number of events 6 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Psychiatric disorders Insomnia	6.3% 10/159 • Number of events 10 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Cough	11.9% 19/159 • Number of events 23 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.2% 13/159 • Number of events 13 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Skin and subcutaneous tissue disorders Pruritus	24.5% 39/159 • Number of events 45 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Skin and subcutaneous tissue disorders Rash	15.7% 25/159 • Number of events 34 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Skin and subcutaneous tissue disorders Skin lesion	6.3% 10/159 • Number of events 19 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	0.00% 0/3 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
Vascular disorders Hypotension	3.8% 6/159 • Number of events 6 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 56 months The analysis population for AEs included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention for first course and second course. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER