Trial Outcomes & Findings for Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) (NCT NCT04428151)

NCT ID: NCT04428151

Last Updated: 2025-12-04

Results Overview

OS was defined as the time from randomization to death due to any cause.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

408 participants

Primary outcome timeframe

Up to approximately 45 months

Results posted on

2025-12-04

Participant Flow

Protocol-specified final analysis for the results, including participant flow, was performed on 374 participants enrolled within the primary completion data cut-off. Analysis of the remaining 34 participants will be included in the End of Trial analysis. Participants who experienced progressive disease in the lenvatinib monotherapy or Standard of Care arms could switch over to receive lenvatinib + pembrolizumab. One participant switched over and received only pembrolizumab.

Participant milestones

Participant milestones
Measure	Lenvatinib + Pembrolizumab Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	SOC Chemotherapy Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Overall Study STARTED	144	142	88
Overall Study Treated	143	140	88
Overall Study Switched Over to Pembrolizumab + Lenvatinib	0	61	18
Overall Study Switched Over to Pembrolizumab	0	1	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	144	142	88

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenvatinib + Pembrolizumab Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	SOC Chemotherapy Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Overall Study Death	100	86	57
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrawal by Subject	2	2	3
Overall Study Participant Ongoing in Study	41	53	28

Baseline Characteristics

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenvatinib + Pembrolizumab n=144 Participants Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	SOC Chemotherapy n=142 Participants Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy n=88 Participants Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Total n=374 Participants Total of all reporting groups
Age, Continuous	62.3 Years STANDARD_DEVIATION 9.0 • n=3 Participants	61.4 Years STANDARD_DEVIATION 10.0 • n=3 Participants	59.9 Years STANDARD_DEVIATION 9.3 • n=6 Participants	61.4 Years STANDARD_DEVIATION 9.5 • n=3 Participants
Sex: Female, Male Female	18 Participants n=3 Participants	19 Participants n=3 Participants	14 Participants n=6 Participants	51 Participants n=3 Participants
Sex: Female, Male Male	126 Participants n=3 Participants	123 Participants n=3 Participants	74 Participants n=6 Participants	323 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	12 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	139 Participants n=3 Participants	137 Participants n=3 Participants	82 Participants n=6 Participants	358 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=3 Participants	2 Participants n=3 Participants	0 Participants n=6 Participants	4 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=3 Participants	2 Participants n=3 Participants	3 Participants n=6 Participants	6 Participants n=3 Participants
Race (NIH/OMB) Asian	35 Participants n=3 Participants	40 Participants n=3 Participants	25 Participants n=6 Participants	100 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	2 Participants n=3 Participants	4 Participants n=3 Participants	2 Participants n=6 Participants	8 Participants n=3 Participants
Race (NIH/OMB) White	104 Participants n=3 Participants	96 Participants n=3 Participants	57 Participants n=6 Participants	257 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	3 Participants n=3 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 0	52 Participants n=3 Participants	58 Participants n=3 Participants	32 Participants n=6 Participants	142 Participants n=3 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 1	92 Participants n=3 Participants	84 Participants n=3 Participants	56 Participants n=6 Participants	232 Participants n=3 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline TPS = <50%	121 Participants n=3 Participants	120 Participants n=3 Participants	74 Participants n=6 Participants	315 Participants n=3 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline TPS = ≥ 50%	23 Participants n=3 Participants	22 Participants n=3 Participants	14 Participants n=6 Participants	59 Participants n=3 Participants

PRIMARY outcome

Timeframe: Up to approximately 45 months

Population: The analysis population consisted of all participants who were randomized prior to the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.

OS was defined as the time from randomization to death due to any cause.

Outcome measures

Outcome measures
Measure	SOC Chemotherapy n=142 Participants Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib + Pembrolizumab n=144 Participants Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Overall Survival (OS)	11.3 Months Interval 9.8 to 14.4	—	8.4 Months Interval 6.9 to 10.3

SECONDARY outcome

Timeframe: Up to approximately 45 months

Population: The analysis population consisted of all participants randomized by the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD.

Outcome measures

Outcome measures
Measure	SOC Chemotherapy n=142 Participants Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib + Pembrolizumab n=144 Participants Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Progression-Free Survival (PFS)	2.8 Months Interval 2.6 to 4.0	—	3.0 Months Interval 2.8 to 3.9

SECONDARY outcome

Timeframe: Up to approximately 45 months

Population: The analysis population consisted of all participants randomized by the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.

ORR was defined as the percentage of participants who had a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Outcome measures

Outcome measures
Measure	SOC Chemotherapy n=142 Participants Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib + Pembrolizumab n=144 Participants Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Objective Response Rate (ORR)	20.4 Percentage of Participants Interval 14.1 to 28.0	—	13.9 Percentage of Participants Interval 8.7 to 20.6

SECONDARY outcome

Timeframe: Up to approximately 45 months

Population: The analysis population consisted of all participants randomized by the primary completion data cut-off who experienced a confirmed CR or PR. Per protocol, participants who received lenvatinib monotherapy were not analyzed.

DOR was defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR.

Outcome measures

Outcome measures
Measure	SOC Chemotherapy n=29 Participants Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib + Pembrolizumab n=20 Participants Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Duration of Response (DOR)	5.9 Months Interval 3.7 to 11.8	—	4.1 Months Interval 3.6 to 7.9

SECONDARY outcome

Timeframe: Up to approximately 5 years

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE was presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 5 years

Outcome measures

Outcome data not reported

Adverse Events

SOC Chemotherapy Switched Over to Pembrolizumab+Lenvatinib

Serious events: 27 serious events

Other events: 55 other events

Deaths: 44 deaths

Lenvatinib + Pembrolizumab

Serious events: 86 serious events

Other events: 139 other events

Deaths: 103 deaths

SOC Chemotherapy

Serious events: 57 serious events

Other events: 135 other events

Deaths: 42 deaths

Lenvatinib Monotherapy

Serious events: 45 serious events

Other events: 80 other events

Deaths: 50 deaths

SOC Chemotherapy Switched Over to Pembrolizumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Lenvatinib Switched Over to Pembrolizumab+Lenvatinib

Serious events: 6 serious events

Other events: 15 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	SOC Chemotherapy Switched Over to Pembrolizumab+Lenvatinib n=61 participants at risk Participants who experienced centrally verified progressive disease (PD) on SOC chemotherapy switched over with Sponsor consultation and received a combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.	Lenvatinib + Pembrolizumab n=143 participants at risk Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	SOC Chemotherapy n=140 participants at risk Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy n=88 participants at risk Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	SOC Chemotherapy Switched Over to Pembrolizumab n=1 participants at risk Participants who experienced centrally verified progressive disease (PD) on SOC chemotherapy switched over with Sponsor consultation and received pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.	Lenvatinib Switched Over to Pembrolizumab+Lenvatinib n=18 participants at risk Participants who experienced centrally verified progressive disease (PD) on lenvatinib monotherapy switched over with Sponsor consultation and received a combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.
Blood and lymphatic system disorders Anaemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Acute coronary syndrome	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Arrhythmia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Atrial fibrillation	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Cardiac tamponade	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Dilated cardiomyopathy	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Myocarditis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Pericardial effusion	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Stress cardiomyopathy	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Abdominal pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Colitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Diarrhoea	1.6% 1/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Dysphagia	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.8% 4/143 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Intestinal perforation	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Large intestine perforation	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Melaena	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Mouth haemorrhage	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Nausea	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Odynophagia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Oesophageal obstruction	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Oral cavity fistula	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Oral pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Orocutaneous fistula	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Pancreatitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Small intestinal obstruction	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Stomatitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.8% 4/143 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Volvulus	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Vomiting	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Asthenia	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Chest pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Death	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Facial pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Fatigue	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders General physical health deterioration	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Localised oedema	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Malaise	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Oedema peripheral	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Pyrexia	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Sudden death	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Systemic inflammatory response syndrome	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Hepatobiliary disorders Cholecystitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Hepatobiliary disorders Hepatic failure	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Hepatobiliary disorders Hepatic pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Hepatobiliary disorders Portal vein thrombosis	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Immune system disorders Anaphylactic shock	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Arthritis bacterial	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Bacteraemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations COVID-19	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations COVID-19 pneumonia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Cellulitis	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Clostridium difficile infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Device related infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Disseminated tuberculosis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Encephalitis bacterial	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Epiglottitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Fungaemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Infected fistula	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Large intestine infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Lower respiratory tract infection	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Lung abscess	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Osteomyelitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Periorbital infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Pneumonia	8.2% 5/61 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	14.0% 20/143 • Number of events 23 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 8/140 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Pneumonia aspiration	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.8% 4/143 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Pneumonia influenzal	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Postoperative wound infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Pulmonary sepsis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Pyomyositis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Respiratory tract infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Sepsis	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Septic shock	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Sinusitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Skin infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Stoma site cellulitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Stoma site infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Vascular device infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Fall	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Head injury	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Tracheal haemorrhage	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Tracheostomy malfunction	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Aspartate aminotransferase increased	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Ejection fraction decreased	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations General physical condition abnormal	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Platelet count decreased	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Weight decreased	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Decreased appetite	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Dehydration	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypophagia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Malnutrition	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Cerebral infarction	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Carotid artery stenosis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Cerebral ischaemia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Cerebrovascular accident	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Cervical radiculopathy	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Encephalopathy	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Occipital neuralgia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Syncope	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Psychiatric disorders Anxiety	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Renal and urinary disorders Acute kidney injury	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Renal and urinary disorders Post infection glomerulonephritis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Renal and urinary disorders Renal failure	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.9% 7/143 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal fistula	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Upper airway necrosis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Arterial haemorrhage	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Embolism	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Hypertension	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Hypotension	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Orthostatic hypotension	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Shock haemorrhagic	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.

Other adverse events

Other adverse events
Measure	SOC Chemotherapy Switched Over to Pembrolizumab+Lenvatinib n=61 participants at risk Participants who experienced centrally verified progressive disease (PD) on SOC chemotherapy switched over with Sponsor consultation and received a combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.	Lenvatinib + Pembrolizumab n=143 participants at risk Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	SOC Chemotherapy n=140 participants at risk Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Lenvatinib Monotherapy n=88 participants at risk Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	SOC Chemotherapy Switched Over to Pembrolizumab n=1 participants at risk Participants who experienced centrally verified progressive disease (PD) on SOC chemotherapy switched over with Sponsor consultation and received pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.	Lenvatinib Switched Over to Pembrolizumab+Lenvatinib n=18 participants at risk Participants who experienced centrally verified progressive disease (PD) on lenvatinib monotherapy switched over with Sponsor consultation and received a combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.
Blood and lymphatic system disorders Anaemia	6.6% 4/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	14.0% 20/143 • Number of events 24 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	26.4% 37/140 • Number of events 40 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	14.8% 13/88 • Number of events 18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Blood and lymphatic system disorders Necrotic lymphadenopathy	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Ear and labyrinth disorders Ear pain	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Endocrine disorders Hypothyroidism	24.6% 15/61 • Number of events 15 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	34.3% 49/143 • Number of events 52 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.6% 12/140 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	31.8% 28/88 • Number of events 28 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Abdominal pain	6.6% 4/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.8% 4/143 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.2% 9/88 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Abdominal pain upper	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.0% 7/88 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Chapped lips	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Constipation	9.8% 6/61 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	17.5% 25/143 • Number of events 28 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	22.9% 32/140 • Number of events 38 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	22.7% 20/88 • Number of events 24 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	16.7% 3/18 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Diarrhoea	24.6% 15/61 • Number of events 20 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	26.6% 38/143 • Number of events 48 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	18.6% 26/140 • Number of events 35 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	28.4% 25/88 • Number of events 39 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	22.2% 4/18 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Dry mouth	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.4% 10/88 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Dyspepsia	4.9% 3/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Dysphagia	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.4% 12/143 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.4% 9/140 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.2% 9/88 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.0% 7/88 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Nausea	19.7% 12/61 • Number of events 14 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	18.2% 26/143 • Number of events 30 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	22.1% 31/140 • Number of events 43 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	13.6% 12/88 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Odynophagia	3.3% 2/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.2% 6/143 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Oral pain	6.6% 4/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.7% 11/143 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Stomatitis	34.4% 21/61 • Number of events 26 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	36.4% 52/143 • Number of events 73 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	20.0% 28/140 • Number of events 30 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	29.5% 26/88 • Number of events 34 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Gastrointestinal disorders Vomiting	8.2% 5/61 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	12.6% 18/143 • Number of events 20 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.3% 13/140 • Number of events 16 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.4% 10/88 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Asthenia	11.5% 7/61 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	21.0% 30/143 • Number of events 33 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	22.1% 31/140 • Number of events 46 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	26.1% 23/88 • Number of events 26 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	16.7% 3/18 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Cyst	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Fatigue	19.7% 12/61 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	25.9% 37/143 • Number of events 38 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	17.1% 24/140 • Number of events 24 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	22.7% 20/88 • Number of events 23 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Gait disturbance	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders General physical health deterioration	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Mucosal inflammation	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Non-cardiac chest pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Oedema peripheral	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.2% 6/143 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.4% 9/140 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Pain	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Pyrexia	6.6% 4/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.1% 13/143 • Number of events 15 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.4% 9/140 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Swelling face	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
General disorders Xerosis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations COVID-19	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.2% 6/143 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Oral candidiasis	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.0% 10/143 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.3% 6/140 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Paronychia	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.7% 15/140 • Number of events 21 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Pneumonia	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 8/143 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.0% 7/140 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Post procedural infection	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Infections and infestations Urinary tract infection	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.3% 9/143 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Injury, poisoning and procedural complications Fall	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Alanine aminotransferase increased	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.7% 11/143 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 8/140 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Amylase increased	6.6% 4/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.8% 4/143 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Aspartate aminotransferase increased	9.8% 6/61 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.1% 13/143 • Number of events 14 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.9% 11/140 • Number of events 19 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.2% 9/88 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	100.0% 1/1 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Blood alkaline phosphatase increased	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.9% 7/143 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.4% 9/140 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Blood creatinine increased	1.6% 1/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.9% 7/143 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	16.7% 3/18 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Blood thyroid stimulating hormone increased	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Lipase increased	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.2% 6/143 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.4% 9/140 • Number of events 14 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Neutrophil count decreased	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	17.1% 24/140 • Number of events 42 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Platelet count decreased	4.9% 3/61 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 8/143 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.2% 9/88 • Number of events 14 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations SARS-CoV-2 test positive	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Investigations Weight decreased	11.5% 7/61 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	18.2% 26/143 • Number of events 28 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	15.7% 22/140 • Number of events 24 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	30.7% 27/88 • Number of events 28 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Decreased appetite	19.7% 12/61 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	23.8% 34/143 • Number of events 35 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	19.3% 27/140 • Number of events 29 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	23.9% 21/88 • Number of events 22 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	27.8% 5/18 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypercalcaemia	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hyperglycaemia	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.4% 9/140 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hyperkalaemia	3.3% 2/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.0% 7/88 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypoalbuminaemia	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.3% 9/143 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypokalaemia	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.0% 10/143 • Number of events 14 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 8/140 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypomagnesaemia	4.9% 3/61 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.2% 6/143 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.6% 12/140 • Number of events 17 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hyponatraemia	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 8/143 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.2% 9/88 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Metabolism and nutrition disorders Hypophosphataemia	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.3% 6/140 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	6.6% 4/61 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.4% 12/143 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.0% 7/140 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	13.6% 12/88 • Number of events 16 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Back pain	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.3% 9/143 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.9% 11/140 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Muscle spasms	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.8% 6/88 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Myalgia	6.6% 4/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	6.3% 9/143 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.3% 13/140 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.1% 8/88 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Neck pain	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.0% 7/140 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.4% 10/88 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.1% 8/88 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Musculoskeletal and connective tissue disorders Temporomandibular pain and dysfunction syndrome	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.2% 6/143 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Dizziness	6.6% 4/61 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.7% 11/143 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 8/140 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.2% 9/88 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Headache	6.6% 4/61 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	12.6% 18/143 • Number of events 19 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.7% 15/140 • Number of events 15 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	12.5% 11/88 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Loss of consciousness	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Paraesthesia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.9% 11/140 • Number of events 16 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.4% 16/140 • Number of events 19 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Nervous system disorders Syncope	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.71% 1/140 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Psychiatric disorders Anxiety	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.2% 6/143 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Psychiatric disorders Confusional state	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Psychiatric disorders Depression	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/143 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Psychiatric disorders Insomnia	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.3% 13/140 • Number of events 14 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Renal and urinary disorders Proteinuria	18.0% 11/61 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	16.8% 24/143 • Number of events 32 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	22.7% 20/88 • Number of events 30 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	16.7% 3/18 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Renal and urinary disorders Urinary retention	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Reproductive system and breast disorders Penile adhesion	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Cough	8.2% 5/61 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.5% 15/143 • Number of events 16 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	15.0% 21/140 • Number of events 22 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.2% 9/88 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Dysphonia	8.2% 5/61 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.4% 12/143 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.0% 7/88 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.8% 14/143 • Number of events 14 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	12.9% 18/140 • Number of events 18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	10.2% 9/88 • Number of events 9 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.0% 7/88 • Number of events 8 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	8.2% 5/61 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.7% 11/143 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.9% 3/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.8% 14/143 • Number of events 17 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.0% 7/140 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	12.5% 11/88 • Number of events 17 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Productive cough	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.5% 5/143 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.6% 12/140 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.6% 1/61 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.1% 3/140 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	16.4% 23/140 • Number of events 23 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.1% 1/88 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	15.7% 22/140 • Number of events 24 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Dry skin	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/143 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.3% 13/140 • Number of events 13 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.7% 5/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.4% 3/88 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Ingrown hair	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Macule	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	14.8% 9/61 • Number of events 10 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	13.3% 19/143 • Number of events 20 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.0% 7/140 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	12.5% 11/88 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/18 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Pruritus	3.3% 2/61 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.0% 10/143 • Number of events 11 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.9% 4/140 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 4 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Rash	8.2% 5/61 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	9.8% 14/143 • Number of events 14 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	18.6% 26/140 • Number of events 31 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	8.0% 7/88 • Number of events 7 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	2.3% 2/88 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/143 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/140 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Hypertension	27.9% 17/61 • Number of events 19 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	42.0% 60/143 • Number of events 77 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 6 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	38.6% 34/88 • Number of events 43 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	100.0% 1/1 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	5.6% 1/18 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Hypotension	3.3% 2/61 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	7.0% 10/143 • Number of events 12 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	3.6% 5/140 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	4.5% 4/88 • Number of events 5 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	16.7% 3/18 • Number of events 3 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.
Vascular disorders Jugular vein thrombosis	0.00% 0/61 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.70% 1/143 • Number of events 1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	1.4% 2/140 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/88 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	0.00% 0/1 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.	11.1% 2/18 • Number of events 2 • Up to approximately 45 months Serious \& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.

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

Restriction type: OTHER