Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024) (NCT NCT02142738)

NCT ID: NCT02142738

Last Updated: 2022-06-13

Results Overview

PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 305 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2022-06-13

Participant Flow

Per protocol, it was planned that participants would be randomized 1:1 to receive either pembrolizumab or investigator-choice standard of care (SOC) chemotherapy and data analysis would be conducted on the two treatment arms: Pembrolizumab and SOC Chemotherapy.

Participant milestones

Measure	Pembrolizumab Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.	SOC Chemotherapy Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Overall Study STARTED	154	151
Overall Study Treated	154	150
Overall Study Chemotherapy Switch to Pembrolizumab	0	83
Overall Study Second Course Pembrolizumab	12	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	154	151

Reasons for withdrawal

Measure	Pembrolizumab Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.	SOC Chemotherapy Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Overall Study Adverse Event	13	9
Overall Study Death	92	112
Overall Study Lost to Follow-up	0	3
Overall Study Withdrawal by Subject	6	7
Overall Study Follow up ended by sponsor	43	20

Baseline Characteristics

Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)

Baseline characteristics by cohort

Measure	Pembrolizumab n=154 Participants Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.	SOC Chemotherapy n=151 Participants Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).	Total n=305 Participants Total of all reporting groups
Age, Continuous	63.9 Years STANDARD_DEVIATION 10.1 • n=93 Participants	64.6 Years STANDARD_DEVIATION 9.5 • n=4 Participants	64.2 Years STANDARD_DEVIATION 9.8 • n=27 Participants
Sex: Female, Male Female	62 Participants n=93 Participants	56 Participants n=4 Participants	118 Participants n=27 Participants
Sex: Female, Male Male	92 Participants n=93 Participants	95 Participants n=4 Participants	187 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	148 Participants n=93 Participants	135 Participants n=4 Participants	283 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	11 Participants n=4 Participants	16 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	25 Participants n=93 Participants	21 Participants n=4 Participants	46 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	125 Participants n=93 Participants	126 Participants n=4 Participants	251 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Status (0, 1 or 2) ECOG = 0	54 Rating n=93 Participants	53 Rating n=4 Participants	107 Rating n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Status (0, 1 or 2) ECOG = 1	99 Rating n=93 Participants	98 Rating n=4 Participants	197 Rating n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Status (0, 1 or 2) ECOG = 2	1 Rating n=93 Participants	0 Rating n=4 Participants	1 Rating n=27 Participants
Histology ADENOCARCINOMA	104 Participants n=93 Participants	108 Participants n=4 Participants	212 Participants n=27 Participants
Histology ADENOSQUAMOUS	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Histology LARGE CELL CARCINOMA	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Histology NON-SQUAMOUS CELL CARCINOMA	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants
Histology POORLY DIFFERENTIATED	9 Participants n=93 Participants	3 Participants n=4 Participants	12 Participants n=27 Participants
Histology SARCOMATOID	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Histology SQUAMOUS CELL CARCINOMA	29 Participants n=93 Participants	26 Participants n=4 Participants	55 Participants n=27 Participants
Histology POORLY DIFFERENTIATED SQUAMOUS CELL CARCINOMA	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Geographic Region of Enrolling Site Non-East Asia	133 Participants n=93 Participants	132 Participants n=4 Participants	265 Participants n=27 Participants
Geographic Region of Enrolling Site East Asia	21 Participants n=93 Participants	19 Participants n=4 Participants	40 Participants n=27 Participants

PRIMARY outcome

Timeframe: Month 6

Population: The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.

PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated.

Outcome measures

Measure	Pembrolizumab n=154 Participants Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.	SOC Chemotherapy n=151 Participants Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Progression Free Survival (PFS) Rate at Month 6	62.1 Percentage of Participants Interval 53.8 to 69.4	50.3 Percentage of Participants Interval 41.9 to 58.2

SECONDARY outcome

Timeframe: 12 months

Population: The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The data cutoff was 10-July-2017. The median OS rate at 12 months is presented.

Outcome measures

Measure	Pembrolizumab n=154 Participants Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.	SOC Chemotherapy n=151 Participants Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Overall Survival (OS) Rate	70.3 Percentage of Participants Interval 62.3 to 76.9	54.8 Percentage of Participants Interval 46.4 to 62.4

SECONDARY outcome

Timeframe: Up to ~1.6 years

Population: The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.

ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. ORR was assessed from enrollment/treatment initiation of a participant through data cutoff of 09-May-2016. The ORR is presented for each treatment group.

Outcome measures

Measure	Pembrolizumab n=154 Participants Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.	SOC Chemotherapy n=151 Participants Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Objective Response Rate (ORR)	44.8 Percentage of Participants Interval 36.8 to 53.0	27.8 Percentage of Participants Interval 20.8 to 35.7

Adverse Events

Pembrolizumab First Course

Serious events: 79 serious events

Other events: 140 other events

Deaths: 103 deaths

SOC Chemotherapy First Course

Serious events: 70 serious events

Other events: 142 other events

Deaths: 60 deaths

SOC Chemotherapy Switched Over to Pembrolizumab First Course

Serious events: 27 serious events

Other events: 72 other events

Deaths: 62 deaths

Pembrolizumab Second Course

Serious events: 2 serious events

Other events: 10 other events

Deaths: 4 deaths

SOC Switched Over to Pembrolizumab Second Course

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Pembrolizumab First Course n=154 participants at risk Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.	SOC Chemotherapy First Course n=150 participants at risk Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).	SOC Chemotherapy Switched Over to Pembrolizumab First Course n=83 participants at risk Qualified participants who received the SOC chemotherapy first course but continued to experience disease progression, at the investigator's discretion, initiated a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \~2 years.	Pembrolizumab Second Course n=12 participants at risk Qualified participants who received the pembrolizumab first course and achieved CR, PR, or stable disease, and progressed after discontinuation, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to 17 cycles (approximately 1 additional year).	SOC Switched Over to Pembrolizumab Second Course n=1 participants at risk One qualified participant received SOC chemotherapy first course, but continued to experience disease progression and at investigator's discretion switched to a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \~2 years. The participant then initiated a second course of pembrolizumab at the same dose and schedule for up to \~1 additional year until documented PD or participant discontinuation.
Blood and lymphatic system disorders Anaemia	1.3% 2/154 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.3% 5/150 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Acute myocardial infarction	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Angina pectoris	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Atrial fibrillation	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Bradycardia	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Cardiac arrest	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Cardiac failure	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Coronary artery disease	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Pericardial effusion	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Pericarditis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Right ventricular failure	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Supraventricular tachycardia	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Ear and labyrinth disorders Vertigo	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Endocrine disorders Hyperthyroidism	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Endocrine disorders Hypophysitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Colitis	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	1.9% 3/154 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Enterocolitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Faecaloma	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Gastric ulcer	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Gastritis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Gastritis erosive	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Intestinal obstruction	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Oesophagitis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Oral lichen planus	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Pancreatitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Stomatitis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Chest pain	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Death	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Face oedema	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Fatigue	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Gait disturbance	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders General physical health deterioration	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Multiple organ dysfunction syndrome	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Oedema peripheral	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Sudden death	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Acute hepatic failure	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Autoimmune hepatitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Immune system disorders Anaphylactic reaction	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Immune system disorders Anaphylactic shock	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Immune system disorders Hypersensitivity	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Appendicitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Bronchitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Bursitis infective	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Cellulitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Clostridium difficile colitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Encephalomyelitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Gastroenteritis viral	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Infectious pleural effusion	1.3% 2/154 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Lower respiratory tract infection	3.2% 5/154 • Number of events 5 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Lymph gland infection	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Meningitis viral	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Neutropenic sepsis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Oral candidiasis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Peritonsillar abscess	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia	3.9% 6/154 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.7% 13/150 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Pulmonary sepsis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Respiratory tract infection	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Sepsis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Septic shock	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Skin infection	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Splenic abscess	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Urosepsis	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Anastomotic complication	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Infusion related reaction	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Pulmonary radiation injury	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Radiation oesophagitis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	1.3% 2/154 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Aspartate aminotransferase increased	0.65% 1/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Bilirubin conjugated increased	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Blood corticotrophin decreased	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Blood creatinine increased	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Cortisol decreased	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Platelet count decreased	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Transaminases increased	0.65% 1/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Dehydration	0.65% 1/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Diabetes mellitus	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Fluid overload	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	1.9% 3/154 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	0.65% 1/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	2.6% 4/154 • Number of events 5 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypovolaemia	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Osteolysis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Spinal pain	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix cancer	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Brain injury	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Brown-Sequard syndrome	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Cerebral haemorrhage	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Cerebral infarction	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Cerebrovascular accident	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Encephalopathy	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Haemorrhagic stroke	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Ischaemic stroke	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Transient ischaemic attack	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Product Issues Device dislocation	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Psychiatric disorders Confusional state	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Psychiatric disorders Insomnia	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Psychiatric disorders Restlessness	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Acute kidney injury	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Hypertensive nephropathy	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Tubulointerstitial nephritis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Reproductive system and breast disorders Ovarian haemorrhage	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.6% 4/154 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.9% 6/154 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.9% 6/154 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Vascular disorders Embolism	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Vascular disorders Ischaemia	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Vascular disorders Superior vena cava occlusion	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Vascular disorders Vasospasm	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.

Other adverse events

Measure	Pembrolizumab First Course n=154 participants at risk Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.	SOC Chemotherapy First Course n=150 participants at risk Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).	SOC Chemotherapy Switched Over to Pembrolizumab First Course n=83 participants at risk Qualified participants who received the SOC chemotherapy first course but continued to experience disease progression, at the investigator's discretion, initiated a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \~2 years.	Pembrolizumab Second Course n=12 participants at risk Qualified participants who received the pembrolizumab first course and achieved CR, PR, or stable disease, and progressed after discontinuation, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to 17 cycles (approximately 1 additional year).	SOC Switched Over to Pembrolizumab Second Course n=1 participants at risk One qualified participant received SOC chemotherapy first course, but continued to experience disease progression and at investigator's discretion switched to a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to \~2 years. The participant then initiated a second course of pembrolizumab at the same dose and schedule for up to \~1 additional year until documented PD or participant discontinuation.
Blood and lymphatic system disorders Anaemia	15.6% 24/154 • Number of events 28 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	51.3% 77/150 • Number of events 98 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.8% 4/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Leukopenia	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.7% 10/150 • Number of events 17 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	1.3% 2/154 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	23.3% 35/150 • Number of events 67 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	12.0% 18/150 • Number of events 32 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Cardiac disorders Bradycardia	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Endocrine disorders Hyperthyroidism	6.5% 10/154 • Number of events 11 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 5/83 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Endocrine disorders Hypothyroidism	10.4% 16/154 • Number of events 16 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.0% 3/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	9.6% 8/83 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Eye disorders Conjunctivitis allergic	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	9.1% 14/154 • Number of events 17 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.7% 10/150 • Number of events 10 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.4% 7/83 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	4.5% 7/154 • Number of events 9 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.7% 7/150 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	22.7% 35/154 • Number of events 43 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	22.0% 33/150 • Number of events 54 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.4% 7/83 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	16.7% 2/12 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	26.6% 41/154 • Number of events 65 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	22.0% 33/150 • Number of events 43 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	21.7% 18/83 • Number of events 22 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	14.9% 23/154 • Number of events 26 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	12.0% 18/150 • Number of events 21 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.8% 4/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Dyspepsia	3.9% 6/154 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 9/150 • Number of events 14 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Dysphagia	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.0% 6/150 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	21.4% 33/154 • Number of events 44 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	45.3% 68/150 • Number of events 129 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	18.1% 15/83 • Number of events 19 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Oesophagitis	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Stomatitis	5.2% 8/154 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	11.3% 17/150 • Number of events 23 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	10.4% 16/154 • Number of events 20 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	24.0% 36/150 • Number of events 65 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	9.6% 8/83 • Number of events 9 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Asthenia	7.8% 12/154 • Number of events 17 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	11.3% 17/150 • Number of events 30 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.4% 7/83 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Chest pain	10.4% 16/154 • Number of events 17 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	10.7% 16/150 • Number of events 16 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 5/83 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Fatigue	24.0% 37/154 • Number of events 45 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	35.3% 53/150 • Number of events 93 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	21.7% 18/83 • Number of events 19 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Influenza like illness	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Malaise	3.9% 6/154 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.0% 12/150 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Oedema peripheral	12.3% 19/154 • Number of events 20 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	10.0% 15/150 • Number of events 19 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	17.5% 27/154 • Number of events 36 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	9.3% 14/150 • Number of events 16 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	9.6% 8/83 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Bronchitis	5.2% 8/154 • Number of events 9 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.7% 4/150 • Number of events 5 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 5/83 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Infected dermal cyst	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Influenza	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Nasopharyngitis	11.7% 18/154 • Number of events 27 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	10.8% 9/83 • Number of events 10 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	16.7% 2/12 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Sinusitis	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Tooth infection	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection	7.1% 11/154 • Number of events 18 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.3% 5/150 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	10.8% 9/83 • Number of events 12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	33.3% 4/12 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	5.8% 9/154 • Number of events 11 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	5.3% 8/150 • Number of events 11 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.8% 4/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Eye injury	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Fall	5.8% 9/154 • Number of events 9 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.7% 4/150 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 5 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Ligament sprain	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	11.0% 17/154 • Number of events 20 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	7.3% 11/150 • Number of events 15 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.8% 4/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Aspartate aminotransferase increased	9.7% 15/154 • Number of events 19 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.7% 7/150 • Number of events 9 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.8% 4/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Blood alkaline phosphatase increased	6.5% 10/154 • Number of events 14 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.7% 4/150 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Blood creatinine increased	7.8% 12/154 • Number of events 15 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	14.0% 21/150 • Number of events 26 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 5/83 • Number of events 9 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Neutrophil count decreased	0.65% 1/154 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	14.0% 21/150 • Number of events 37 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Platelet count decreased	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	12.7% 19/150 • Number of events 28 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations Weight decreased	9.1% 14/154 • Number of events 15 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	7.3% 11/150 • Number of events 12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	7.2% 6/83 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	16.7% 2/12 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Investigations White blood cell count decreased	0.65% 1/154 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	11.3% 17/150 • Number of events 25 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	21.4% 33/154 • Number of events 36 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	32.7% 49/150 • Number of events 71 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	14.5% 12/83 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	16.7% 2/12 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	6.5% 10/154 • Number of events 17 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 9/150 • Number of events 10 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperkalaemia	5.2% 8/154 • Number of events 9 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.0% 6/150 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	5.2% 8/154 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.7% 7/150 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypomagnesaemia	2.6% 4/154 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.7% 13/150 • Number of events 18 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 5/83 • Number of events 5 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	7.1% 11/154 • Number of events 17 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.0% 12/150 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.4% 7/83 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	22.1% 34/154 • Number of events 47 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	11.3% 17/150 • Number of events 21 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	19.3% 16/83 • Number of events 18 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Muscle spasms	6.5% 10/154 • Number of events 10 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 10/154 • Number of events 11 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 5/83 • Number of events 5 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	5.8% 9/154 • Number of events 12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.7% 10/150 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	7.2% 6/83 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Dizziness	13.0% 20/154 • Number of events 25 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.0% 12/150 • Number of events 16 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.0% 5/83 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Dysgeusia	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.7% 13/150 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Headache	7.1% 11/154 • Number of events 17 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.7% 7/150 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.4% 7/83 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Neuropathy peripheral	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.7% 10/150 • Number of events 10 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Nervous system disorders Tremor	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Psychiatric disorders Insomnia	10.4% 16/154 • Number of events 18 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	7.3% 11/150 • Number of events 11 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.4% 7/83 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	18.8% 29/154 • Number of events 44 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	14.0% 21/150 • Number of events 24 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	19.3% 16/83 • Number of events 17 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	26.6% 41/154 • Number of events 50 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	16.0% 24/150 • Number of events 29 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	10.8% 9/83 • Number of events 10 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.1% 11/154 • Number of events 11 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.3% 5/150 • Number of events 5 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.4% 7/83 • Number of events 10 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Hiccups	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	6.7% 10/150 • Number of events 12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.2% 1/83 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.65% 1/154 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	1.3% 2/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	3.6% 3/83 • Number of events 3 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Alopecia	1.3% 2/154 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	10.0% 15/150 • Number of events 15 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Dry skin	11.0% 17/154 • Number of events 18 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.4% 7/83 • Number of events 7 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/154 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/150 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	20.8% 32/154 • Number of events 46 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.0% 6/150 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	15.7% 13/83 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	16.7% 2/12 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	18.2% 28/154 • Number of events 43 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	4.7% 7/150 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	9.6% 8/83 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 7/154 • Number of events 8 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.67% 1/150 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	7.2% 6/83 • Number of events 6 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Vascular disorders Hypertension	7.1% 11/154 • Number of events 13 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.7% 4/150 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/83 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/12 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.
Vascular disorders Hypotension	2.6% 4/154 • Number of events 5 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.7% 4/150 • Number of events 4 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	2.4% 2/83 • Number of events 2 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	8.3% 1/12 • Number of events 1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.	0.00% 0/1 • Up to approximately 80 months. All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
• Publication restrictions are in place

Restriction type: OTHER