Trial Outcomes & Findings for Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063) (NCT NCT03019588)

NCT ID: NCT03019588

Last Updated: 2023-03-30

Results Overview

OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

94 participants

Primary outcome timeframe

Up to approximately 50 months

Results posted on

2023-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab 200 mg Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Overall Study STARTED	47	47
Overall Study Treated	47	44
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	47	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab 200 mg Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Overall Study Death	44	46
Overall Study Study terminated by Sponsor	3	1

Baseline Characteristics

Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab 200 mg n=47 Participants Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 n=47 Participants Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.	Total n=94 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 10.4 • n=5 Participants	59.0 years STANDARD_DEVIATION 11.2 • n=7 Participants	58.5 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	37 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Time to progression on first-line therapy < 6 months	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Time to progression on first-line therapy >= 6 months	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ECOG = 0	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ECOG = 1	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 50 months

Population: Analysis population includes all randomized participants.

OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=47 Participants Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 n=47 Participants Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Overall Survival (OS)	8.4 Months Interval 4.0 to 9.5	7.7 Months Interval 5.4 to 11.3

PRIMARY outcome

Timeframe: Up to approximately 50 months

Population: Analysis population includes all randomized participants.

PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS as assessed by blinded independent central review will be presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=47 Participants Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 n=47 Participants Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	1.9 Months Interval 1.4 to 2.8	4.0 Months Interval 2.7 to 6.2

SECONDARY outcome

Timeframe: Up to approximately 50 months

Population: Analysis population includes all randomized participants.

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=47 Participants Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 n=47 Participants Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Objective Response Rate (ORR) Per RECIST 1.1	12.8 Percentage of participants Interval 4.8 to 25.7	19.1 Percentage of participants Interval 9.1 to 33.3

SECONDARY outcome

Timeframe: Up to approximately 50 months

Population: Analysis population includes all randomized participants who received at least one dose of study treatment.

An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=47 Participants Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 n=44 Participants Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Number of Participants Who Experience an Adverse Event (AE)	46 Participants	43 Participants

SECONDARY outcome

Timeframe: Up to approximately 25 months

Population: Analysis population includes all randomized participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg n=47 Participants Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 n=44 Participants Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Number of Participants Who Discontinue Study Treatment Due to an AE	2 Participants	7 Participants

Adverse Events

Pembrolizumab 200 mg

Serious events: 13 serious events

Other events: 46 other events

Deaths: 44 deaths

Paclitaxel 80 mg/m^2

Serious events: 14 serious events

Other events: 43 other events

Deaths: 46 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

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

Serious adverse events
Measure	Pembrolizumab 200 mg n=47 participants at risk Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 n=44 participants at risk Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Renal and urinary disorders Acute kidney injury	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Blood and lymphatic system disorders Anaemia	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Ileus	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
General disorders Pyrexia	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Endocrine disorders Adrenal insufficiency	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
General disorders Asthenia	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Asthma	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Hepatobiliary disorders Biliary obstruction	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Bone pain	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Hepatobiliary disorders Hepatic function abnormal	2.1% 1/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Vascular disorders Hypovolaemic shock	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Pneumonia	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Post procedural infection	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Rhinitis	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Sepsis	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Endocrine disorders Thyroiditis	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Upper limb fracture	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Vomiting	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
General disorders Fatigue	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Herpes zoster	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Nervous system disorders Ischaemic stroke	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Neutrophil count decreased	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	4.5% 2/44 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Peritonitis	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Urinary tract infection	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations White blood cell count decreased	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.

Other adverse events
Measure	Pembrolizumab 200 mg n=47 participants at risk Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Paclitaxel 80 mg/m^2 n=44 participants at risk Participants receive paclitaxel 80 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Blood and lymphatic system disorders Anaemia	36.2% 17/47 • Number of events 21 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	45.5% 20/44 • Number of events 26 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 17 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Blood and lymphatic system disorders Leukopenia	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	9.1% 4/44 • Number of events 22 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Blood and lymphatic system disorders Neutropenia	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	13.6% 6/44 • Number of events 19 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Endocrine disorders Hyperthyroidism	6.4% 3/47 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	0.00% 0/44 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Endocrine disorders Hypothyroidism	10.6% 5/47 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal distension	8.5% 4/47 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	23.4% 11/47 • Number of events 12 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	13.6% 6/44 • Number of events 9 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain upper	12.8% 6/47 • Number of events 7 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	15.9% 7/44 • Number of events 8 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Ascites	6.4% 3/47 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	9.1% 4/44 • Number of events 4 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Constipation	14.9% 7/47 • Number of events 8 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	15.9% 7/44 • Number of events 8 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	17.0% 8/47 • Number of events 21 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	18.2% 8/44 • Number of events 8 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Dyspepsia	10.6% 5/47 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Nausea	21.3% 10/47 • Number of events 11 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	20.5% 9/44 • Number of events 10 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Gastrointestinal disorders Vomiting	17.0% 8/47 • Number of events 11 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	9.1% 4/44 • Number of events 7 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
General disorders Asthenia	12.8% 6/47 • Number of events 7 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	13.6% 6/44 • Number of events 6 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
General disorders Fatigue	19.1% 9/47 • Number of events 9 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	15.9% 7/44 • Number of events 9 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
General disorders Influenza like illness	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
General disorders Oedema peripheral	8.5% 4/47 • Number of events 4 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 4 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
General disorders Pyrexia	17.0% 8/47 • Number of events 9 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	15.9% 7/44 • Number of events 11 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Pneumonia	0.00% 0/47 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	11.4% 5/44 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Infections and infestations Upper respiratory tract infection	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	11.4% 5/44 • Number of events 6 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Alanine aminotransferase increased	10.6% 5/47 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	15.9% 7/44 • Number of events 8 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	12.8% 6/47 • Number of events 7 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	15.9% 7/44 • Number of events 7 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Blood albumin decreased	6.4% 3/47 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Blood alkaline phosphatase increased	19.1% 9/47 • Number of events 10 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Blood bilirubin increased	8.5% 4/47 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Gamma-glutamyltransferase increased	14.9% 7/47 • Number of events 7 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Neutrophil count decreased	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	38.6% 17/44 • Number of events 55 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations Weight decreased	10.6% 5/47 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	9.1% 4/44 • Number of events 4 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Investigations White blood cell count decreased	2.1% 1/47 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	29.5% 13/44 • Number of events 49 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	10.6% 5/47 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	36.4% 16/44 • Number of events 19 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperglycaemia	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypoalbuminaemia	29.8% 14/47 • Number of events 16 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	13.6% 6/44 • Number of events 7 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypokalaemia	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 6 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyponatraemia	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypoproteinaemia	6.4% 3/47 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	2.3% 1/44 • Number of events 1 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 4/47 • Number of events 5 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	4.5% 2/44 • Number of events 4 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Back pain	14.9% 7/47 • Number of events 7 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	4.5% 2/44 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
Nervous system disorders Dizziness	4.3% 2/47 • Number of events 2 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.	6.8% 3/44 • Number of events 3 • Up to approximately 50 months All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.