Trial Outcomes & Findings for Study of Ulevostinag (MK-1454) Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001) (NCT NCT03010176)

Last Updated: 2025-10-29

Results Overview

DLTs were assessed during the first cycle (21 days) \& are defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia, Gr 4 thrombocytopenia, Gr 3 thrombocytopenia (if associated with clinically significant bleeding); nonhematologic adverse event (AE) ≥ Gr 3 (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention is required, leads to hospitalization, or persists for \>1 week); Gr 3 or 4 febrile neutropenia; drug-related toxicity that causes treatment discontinuation or dose delay \>7 days between consecutive doses during Cycle 1; drug-related toxicity that causes a \>2 week delay in Cycle 2 initiation; elevated aspartate aminotransferase or alanine aminotransferase lab value that is ≥3× upper limit of normal (ULN) \& an elevated total bilirubin value ≥2× ULN \& an alkaline phosphatase value \<2× ULN, in which no alternative reasons can be found; ≥Gr 2 immune-mediated uveitis; or Gr 5 toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

156 participants

Primary outcome timeframe

Cycle 1 (21-day cycle)

Results posted on

2025-10-29

Participant Flow

Evaluation of Part 2 Cohort C (anti-PD-1/PD-L1 treatment-naïve solid tumors with liver metastases/lesions) was not pursued. No participants were enrolled in Part 2 Cohort C.

Participant milestones

Participant milestones
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via intratumoral (IT) injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Overall Study STARTED	32	52	26	21	25
Overall Study Treated	32	52	26	21	25
Overall Study Switched From Part 1 Arm 1 to Part 1 Arm 2	14	0	0	0	0
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	32	52	26	21	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via intratumoral (IT) injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Overall Study Death	21	35	19	19	14
Overall Study Lost to Follow-up	0	0	0	0	1
Overall Study Physician Decision	0	4	0	1	0
Overall Study Sponsor Decision	0	4	4	1	6
Overall Study Withdrawal by Subject	11	9	3	0	4

Baseline Characteristics

Study of Ulevostinag (MK-1454) Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=32 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=52 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=26 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=21 Participants Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=25 Participants Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort C: Anti-PD-1/PD-L1 TrT-Naïve Solid Tumors-Liver Participants with solid tumors with liver metastases/lesions who were anti-PD-1/PD-L1 treatment-naïve were to receive ulevostinag at the preliminary RP2D based on Part 1: ulevostinag+pembro (visceral lesions) treatment arm via IT injection in a to-be-determined dose and frequency, based on data from Arm 3, PLUS pembrolizumab mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Total n=156 Participants Total of all reporting groups
Age, Continuous	56.9 Years STANDARD_DEVIATION 14.1 • n=5 Participants	60.1 Years STANDARD_DEVIATION 14.0 • n=7 Participants	59.1 Years STANDARD_DEVIATION 10.1 • n=5 Participants	60.2 Years STANDARD_DEVIATION 8.5 • n=4 Participants	49.3 Years STANDARD_DEVIATION 10.9 • n=21 Participants	—	57.5 Years STANDARD_DEVIATION 12.7 • n=8 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	31 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	25 Participants n=21 Participants	0 Participants n=8 Participants	88 Participants n=8 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	21 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	68 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	44 Participants n=7 Participants	25 Participants n=5 Participants	20 Participants n=4 Participants	12 Participants n=21 Participants	0 Participants n=8 Participants	131 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	12 Participants n=21 Participants	0 Participants n=8 Participants	21 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	19 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	50 Participants n=7 Participants	20 Participants n=5 Participants	12 Participants n=4 Participants	7 Participants n=21 Participants	0 Participants n=8 Participants	115 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants	0 Participants n=8 Participants	16 Participants n=8 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21-day cycle)

Population: All participants who received at least 1 dose of study treatment and were either observed for safety for 21 days after the first dose of treatment or experienced a DLT prior to 21 days after the first dose of treatment

Outcome measures

Outcome measures
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=31 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=65 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=25 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Part 1: Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE 4.0)	15.1 Percentage of participants Interval 6.6 to 21.8	10.4 Percentage of participants Interval 5.3 to 14.5	0 Percentage of participants Interval 0.0 to 6.0	—	—

PRIMARY outcome

Timeframe: Up to approximately 2 years

Population: All participants who received at least 1 dose of study treatment

AEs are defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment, is also an AE.

Outcome measures

Outcome measures
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=32 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=66 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=26 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=21 Participants Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=25 Participants Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Parts 1 and 2: Number of Participants Who Experienced One or More Adverse Events (AEs)	32 Participants	66 Participants	26 Participants	21 Participants	25 Participants

PRIMARY outcome

Timeframe: Up to approximately 2 years

Population: All participants who received at least 1 dose of study treatment

Outcome measures

Outcome measures
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=32 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=66 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=26 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=21 Participants Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=25 Participants Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an AE	3 Participants	7 Participants	3 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, 6, 12, and 24 hours postdose. Each cycle was 21 days.

Population: All participants who complied with the protocol sufficiently to ensure that the data they generated were likely to exhibit the effects of treatment, according to the underlying scientific model

The AUC0-24 is a measure of the amount of drug in the blood over time for 0 hours to 24 hours. The AUC0-24 of ulevostinag administered via IT injection as monotherapy and the AUC0-24 of ulevostinag administered via IT injection as combination therapy with pembrolizumab IV infusion were evaluated.

Outcome measures

Outcome measures
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=28 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=48 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=22 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=13 Participants Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=20 Participants Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Parts 1 and 2: Ulevostinag Area Under the Plasma Drug Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)	8.62 nM*hr Interval 0.31 to 34.67	6.59 nM*hr Interval 0.57 to 41.43	5.88 nM*hr Interval 0.11 to 24.3	6.24 nM*hr Interval 1.78 to 12.4	7.98 nM*hr Interval 2.43 to 13.48

SECONDARY outcome

Timeframe: Cycle 1 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, 6, 12, and 24 hours postdose; Cycle 2 Day 1: Predose, at end of IT injection (up to 15 minutes) and 0.5, 1, 1.5, 4, and 6 hours postdose. Each cycle was 21 days.

Cmin is a measure of the minimum amount of drug in the plasma after the dose is given. The Cmin of ulevostinag administered via IT injection as monotherapy and the Cmin of ulevostinag administered via IT injection as combination therapy with pembrolizumab IV infusion were evaluated.

Outcome measures

Outcome measures
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=28 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=48 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=22 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=13 Participants Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=20 Participants Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Parts 1 and 2: Ulevostinag Minimum Plasma Concentration (Cmin)	0.18 ng/mL Interval 0.06 to 3.09	0.12 ng/mL Interval 0.05 to 1.16	0.08 ng/mL Interval 0.05 to 6.83	0.09 ng/mL Interval 0.05 to 0.56	0.13 ng/mL Interval 0.05 to 0.44

SECONDARY outcome

Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. The Cmax of ulevostinag administered via IT injection as monotherapy and the Cmax of ulevostinag administered via IT injection as combination therapy with pembrolizumab IV infusion were evaluated.

Outcome measures

Outcome measures
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=28 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=48 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=22 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=13 Participants Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=20 Participants Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Parts 1 and 2: Ulevostinag Maximum Plasma Concentration (Cmax)	6.56 nM Interval 0.15 to 49.9	5.38 nM Interval 0.21 to 45.5	7.08 nM Interval 0.43 to 48.9	6.75 nM Interval 0.07 to 40.9	8.4 nM Interval 0.92 to 23.8

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 1, 2, and 4, and every 4 cycles thereafter up to Cycle 35 (up to 2 years). Each cycle was 21 days.

Cmin is a measure of the minimum amount of drug in the plasma after the dose is given. The Cmin of pembrolizumab IV infusion in combination with MK-1454 administered via IT injection was evaluated.

Outcome measures

Outcome measures
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=32 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=18 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=15 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=19 Participants Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Parts 1 and 2: Pembrolizumab Minimum Plasma Concentration (Cmin)	14.5 ng/mL Interval 5.03 to 68.3	14.25 ng/mL Interval 5.5 to 81.7	17.7 ng/mL Interval 7.09 to 43.2	13.6 ng/mL Interval 3.54 to 22.7	—

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: All participants with a baseline scan that demonstrated measurable disease by investigator assessment, and who received a dose of study medicine

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR of ulevostinag at the preliminary RP2D in combination with pembrolizumab will be assessed by RECIST 1.1 modified to follow a maximum of 10 target lesions with a maximum of 5 target lesions per organ.

Outcome measures

Outcome measures
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=30 Participants Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=62 Participants Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=26 Participants Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=21 Participants Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=25 Participants Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Parts 1 and 2: Objective Response Rate (ORR) As Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	0.0 Percentage of participants Interval 0.0 to 11.6	16.1 Percentage of participants Interval 8.0 to 27.7	3.8 Percentage of participants Interval 0.1 to 19.6	4.8 Percentage of participants Interval 0.1 to 23.8	4.0 Percentage of participants Interval 0.1 to 20.4

Adverse Events

Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions)

Serious events: 14 serious events

Other events: 32 other events

Deaths: 21 deaths

Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions)

Serious events: 33 serious events

Other events: 65 other events

Deaths: 45 deaths

Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions)

Serious events: 10 serious events

Other events: 26 other events

Deaths: 19 deaths

Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory

Serious events: 11 serious events

Other events: 21 other events

Deaths: 19 deaths

Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC

Serious events: 7 serious events

Other events: 25 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=32 participants at risk Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=66 participants at risk Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=26 participants at risk Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=21 participants at risk Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=25 participants at risk Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Gastrointestinal disorders Diarrhoea	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Dysphagia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Anaemia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Pericardial effusion	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Adrenal insufficiency	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Abdominal pain	3.1% 1/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Colitis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Constipation	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastritis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Pancreatitis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Vomiting	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Fatigue	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Injection site pain	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Non-cardiac chest pain	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Pyrexia	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Malignant biliary obstruction	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Immune system disorders Cytokine release syndrome	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Bacteraemia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Injection site infection	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Laryngitis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Lower respiratory tract infection	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Mastitis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Oral infection	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pharyngitis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia aspiration	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Sepsis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Skin infection	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Urinary tract infection	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Wound infection	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Accidental exposure to product	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Product dispensing error	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood alkaline phosphatase increased	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood calcium increased	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Cerebrovascular accident	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Acute kidney injury	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Haematuria	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Renal failure	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Renal infarct	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Deep vein thrombosis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Haemorrhage	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Hypotension	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.

Other adverse events

Other adverse events
Measure	Part 1 Arm 1: Ulevostinag (Cut/Subcut Lesions) n=32 participants at risk Participants with cutaneous (cut) or subcutaneous (subcut) lesions received escalating doses of ulevostinag monotherapy via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond for up to 35 cycles (up to approximately 2 years).	Part 1 Arm 2: Ulevostinag+Pembro (Cut/Subcut Lesions) n=66 participants at risk Participants with cut or subcut lesions received escalating doses of ulevostinag via IT injection on Days 1, 8, and 15 of each 21-day cycle for Cycles 1, 2, and 3 and then on Day 1 of each 21-day cycle for Cycles 4 and beyond PLUS pembrolizumab (pembro) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Note: This combination therapy treatment group includes switch-over participants from Part 1 Arm 1.	Part 1 Arm 3: Ulevostinag+Pembro (Visceral Lesions) n=26 participants at risk Participants with visceral lesions received escalating doses of ulevostinag via IT injection at escalating dose frequencies (Day 1 of each 21-day cycle for up to 35 cycles, then Days 1 and 8 of each 21-day cycle for two cycles, then Day 1 of each 21 day cycle up to 35 cycles, then Days 1, 8, and 15 of each 21-day cycle for two cycles followed by Day 1 of each 21-day cycle up to 35 cycles), PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (approximately 2 years).	Part 2 Cohort A: HNSCC Anti-PD-1/PD-L1 Refractory n=21 participants at risk Participants with head and neck squamous cell carcinoma (HNSCC) who were anti-programmed cell death-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) refractory received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).	Part 2 Cohort B: Anti-PD-1/PD-L1 TrT-Naïve or Refractory TNBC n=25 participants at risk Participants with triple-negative breast cancer (TNBC) who were anti-PD-1/PD-L1 treatment (TrT)-naïve or who had refractory unresectable locally advanced or metastatic TNBC received ulevostinag via IT injection on Days 1, 8, and 15 of Cycles 1 and 2 and on Day 1 of each 21-day cycle from Cycle 3 onward (up to a total of 35 cycles) PLUS pembrolizumab via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years).
Blood and lymphatic system disorders Anaemia	43.8% 14/32 • Number of events 17 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	40.9% 27/66 • Number of events 42 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.1% 6/26 • Number of events 11 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	52.4% 11/21 • Number of events 14 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	28.0% 7/25 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Leukocytosis	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Lymph node pain	6.2% 2/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Lymphadenopathy	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Sinus tachycardia	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Tachycardia	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Ear and labyrinth disorders Ear pain	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Adrenal insufficiency	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Abdominal pain	18.8% 6/32 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	19.2% 5/26 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Constipation	25.0% 8/32 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	22.7% 15/66 • Number of events 16 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.7% 2/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.8% 5/21 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Diarrhoea	18.8% 6/32 • Number of events 11 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	21.2% 14/66 • Number of events 26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.7% 2/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Dry mouth	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Dysphagia	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Nausea	50.0% 16/32 • Number of events 22 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	24.2% 16/66 • Number of events 21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.1% 6/26 • Number of events 10 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	38.1% 8/21 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Vomiting	18.8% 6/32 • Number of events 13 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	13.6% 9/66 • Number of events 17 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	30.8% 8/26 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	14.3% 3/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Asthenia	9.4% 3/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.4% 4/26 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.0% 4/25 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Chest pain	9.4% 3/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Chills	53.1% 17/32 • Number of events 55 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	36.4% 24/66 • Number of events 59 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	46.2% 12/26 • Number of events 28 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.8% 5/21 • Number of events 11 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	36.0% 9/25 • Number of events 19 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Face oedema	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Fatigue	53.1% 17/32 • Number of events 19 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	42.4% 28/66 • Number of events 34 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	46.2% 12/26 • Number of events 25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.8% 5/21 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Influenza like illness	21.9% 7/32 • Number of events 11 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	22.7% 15/66 • Number of events 45 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.8% 5/21 • Number of events 14 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Injection site erythema	15.6% 5/32 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Injection site haemorrhage	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Injection site inflammation	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Injection site necrosis	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Injection site pain	59.4% 19/32 • Number of events 34 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	31.8% 21/66 • Number of events 46 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.1% 6/26 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	19.0% 4/21 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.0% 4/25 • Number of events 7 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Injection site reaction	9.4% 3/32 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	13.6% 9/66 • Number of events 12 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.0% 3/25 • Number of events 10 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Injection site swelling	9.4% 3/32 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Malaise	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Non-cardiac chest pain	6.2% 2/32 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Oedema peripheral	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 7 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.7% 2/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Pyrexia	75.0% 24/32 • Number of events 58 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	57.6% 38/66 • Number of events 85 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	76.9% 20/26 • Number of events 51 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	52.4% 11/21 • Number of events 20 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	80.0% 20/25 • Number of events 53 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hepatic pain	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.4% 4/26 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Immune system disorders Cytokine release syndrome	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.4% 4/26 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Bronchitis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Nasopharyngitis	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Skin infection	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Urinary tract infection	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Procedural pain	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Wound secretion	12.5% 4/32 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Alanine aminotransferase increased	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.5% 3/26 • Number of events 7 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	14.3% 3/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Aspartate aminotransferase increased	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	30.8% 8/26 • Number of events 12 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.0% 3/25 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood alkaline phosphatase increased	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 11/66 • Number of events 14 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.1% 6/26 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood bilirubin increased	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.7% 2/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood creatine phosphokinase increased	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Gamma-glutamyltransferase increased	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 11/66 • Number of events 11 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	19.2% 5/26 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Lipase increased	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.5% 3/26 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Lymphocyte count decreased	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Weight decreased	9.4% 3/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.2% 10/66 • Number of events 11 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.5% 3/26 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	14.3% 3/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	25.0% 8/32 • Number of events 10 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	19.7% 13/66 • Number of events 14 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	34.6% 9/26 • Number of events 15 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.8% 5/21 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	14.3% 3/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	15.6% 5/32 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 10 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	14.3% 3/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyperkalaemia	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 7 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.1% 8/66 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.7% 2/26 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	9.4% 3/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	15.6% 5/32 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 11/66 • Number of events 30 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.7% 2/26 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypophosphataemia	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Iron deficiency	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	15.6% 5/32 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 11/66 • Number of events 17 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.5% 3/26 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	18.8% 6/32 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.5% 3/26 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Groin pain	9.4% 3/32 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Myalgia	18.8% 6/32 • Number of events 18 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.1% 6/66 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.1% 6/26 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 16 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.8% 5/21 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 2/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 11/66 • Number of events 20 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	14.3% 3/21 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm swelling	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	21.9% 7/32 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.5% 3/26 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	14.3% 3/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Dizziness	9.4% 3/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.5% 3/26 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Headache	34.4% 11/32 • Number of events 18 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	22.7% 15/66 • Number of events 28 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.4% 4/26 • Number of events 7 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Neuropathy peripheral	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.1% 4/66 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Tremor	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Psychiatric disorders Anxiety	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Psychiatric disorders Insomnia	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Acute kidney injury	0.00% 0/32 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.7% 2/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Dysuria	6.2% 2/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 4/32 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	19.7% 13/66 • Number of events 15 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.7% 2/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 4/32 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.1% 8/66 • Number of events 8 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.5% 3/26 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	12.5% 4/32 • Number of events 7 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.1% 8/66 • Number of events 10 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	6.2% 2/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 2/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 2/32 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	15.6% 5/32 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Erythema	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Night sweats	25.0% 8/32 • Number of events 20 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 14 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.8% 1/26 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	6.2% 2/32 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	27.3% 18/66 • Number of events 23 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	19.2% 5/26 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	14.3% 3/21 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	6.2% 2/32 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	13.6% 9/66 • Number of events 10 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.1% 1/32 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	12.1% 8/66 • Number of events 10 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/25 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Skin ulcer	9.4% 3/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 6 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	9.5% 2/21 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Hypertension	9.4% 3/32 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.5% 3/66 • Number of events 3 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/26 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/21 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Hypotension	15.6% 5/32 • Number of events 5 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	13.6% 9/66 • Number of events 9 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.4% 4/26 • Number of events 4 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.8% 1/21 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to approximately 2 years All-Cause Mortality population includes all allocated participants. Serious and Other Adverse Events population includes all participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER