Trial Outcomes & Findings for A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06) (NCT NCT03322566)

NCT ID: NCT03322566

Last Updated: 2022-01-24

Results Overview

ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 233 participants
• Primary outcome timeframe: Assessed every 12 weeks up to 24 months
• Results posted on: 2022-01-24

Participant Flow

Participants took part in the study at 65 investigative sites in 14 countries from 09 January 2018 to 13 December 2018.

Phase 3 design of the study has been amended soon after it had started to a prospectively randomized phase 2 study. At the time of amendment existing participants were given a choice to move/participate in the new phase 2 study, and some participants who chose to discontinue the study at phase 3 were assigned to "study terminated by sponsor" as the reason for not completing the study in disposition table. The results posted are combined in the prospectively redesigned phase 2 trial.

Participant milestones

Measure	Pembrolizumab + Chemotherapy + Epacadostat Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Epacadostat Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
Overall Study STARTED	91	87	55
Overall Study COMPLETED	46	42	22
Overall Study NOT COMPLETED	45	45	33

Reasons for withdrawal

Measure	Pembrolizumab + Chemotherapy + Epacadostat Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Epacadostat Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
Overall Study Death	34	35	23
Overall Study Physician Decision	6	7	2
Overall Study Withdrawal by Subject	4	3	6
Overall Study Lost to Follow-up	0	0	1
Overall Study Study terminated by sponsor	1	0	1

Baseline Characteristics

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

Baseline characteristics by cohort

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=91 Participants Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=87 Participants Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Epacadostat n=55 Participants Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.	Total n=233 Participants Total of all reporting groups
Age, Continuous	63.0 years STANDARD_DEVIATION 11.7 • n=5 Participants	63.6 years STANDARD_DEVIATION 8.8 • n=7 Participants	62.8 years STANDARD_DEVIATION 8.4 • n=5 Participants	63.2 years STANDARD_DEVIATION 9.9 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	30 Participants n=7 Participants	16 Participants n=5 Participants	79 Participants n=4 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	57 Participants n=7 Participants	39 Participants n=5 Participants	154 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian Or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	11 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black Or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	78 Participants n=5 Participants	75 Participants n=7 Participants	53 Participants n=5 Participants	206 Participants n=4 Participants
Race/Ethnicity, Customized Race · Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	86 Participants n=5 Participants	85 Participants n=7 Participants	52 Participants n=5 Participants	223 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Assessed every 12 weeks up to 24 months

Population: ITT population consisted of all participants randomized in treatment arm Pembrolizumab+Epacadostat+Chemotherapy and treatment arm Pembrolizumab+Chemothrapy. This is not a primary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.

ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).

Outcome measures

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=91 Participants Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=87 Participants Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo	26.4 percentage of participants Interval 17.7 to 36.7	44.8 percentage of participants Interval 34.1 to 55.9

SECONDARY outcome

Timeframe: Up to 24 months

Population: ITT population consisted of all participants randomized in treatment arm Pembrolizumab+Epacadostat+Chemotherapy and treatment arm Pembrolizumab+Chemothrapy. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.

Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.

Outcome measures

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=91 Participants Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=87 Participants Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo	8.0 months Interval 4.2 to 10.2	8.2 months Interval 6.0 to Upper bound is not estimable

SECONDARY outcome

Timeframe: Up to 24 months

Population: ITT population consisted of all participants randomized in treatment arm Pembrolizumab+Epacadostat+Chemotherapy and treatment arm Pembrolizumab+Chemothrapy. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.

Defined as the time from randomization to death due to any cause.

Outcome measures

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=91 Participants Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=87 Participants Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo	NA months Median could not be estimated because there were not enough events	NA months Median could not be estimated because there were not enough events

SECONDARY outcome

Timeframe: Up to 24 months

Population: ITT population consisted of all participants randomized in treatment arm Pembrolizumab+Epacadostat+Chemotherapy and treatment arm Pembrolizumab+Chemothrapy. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.

Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.

Outcome measures

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=91 Participants Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=87 Participants Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo	NA months Interval 1.1 to 7.0 Median could not be estimated because there were not enough events	7.0 months Interval 1.2 to 8.0

SECONDARY outcome

Timeframe: Up to 25 months

Population: All Subjects as Treated consists of all randomized participants who received at least one dose of study treatment. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.

An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=90 Participants Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=86 Participants Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)	89 Participants	82 Participants

SECONDARY outcome

Timeframe: Up to 25 months

Population: All Subjects as Treated consists of all randomized participants who received at least one dose of study treatment. This is not a secondary outcome measure for treatment arm Pembrolizumab+Epacadostat per protocol.

An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.

Outcome measures

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=90 Participants Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=86 Participants Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs	37 Participants	35 Participants

Adverse Events

Pembrolizumab + Chemotherapy + Epacadostat

Serious events: 47 serious events

Other events: 87 other events

Deaths: 38 deaths

Pembrolizumab + Chemotherapy + Placebo

Serious events: 41 serious events

Other events: 81 other events

Deaths: 35 deaths

Pembrolizumab + Epacadostat

Serious events: 20 serious events

Other events: 51 other events

Deaths: 26 deaths

Total

Serious events: 108 serious events

Other events: 219 other events

Deaths: 99 deaths

Serious adverse events

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=90 participants at risk Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=86 participants at risk Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Epacadostat n=52 participants at risk Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.	Total n=228 participants at risk Total
Gastrointestinal disorders Abdominal pain upper	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	2.2% 2/90 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Agitation	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthropathy	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Atrial fibrillation	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.3% 3/228 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Atrioventricular block complete	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Hepatobiliary disorders Autoimmune hepatitis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Breakthrough pain	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Bronchitis	3.3% 3/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.8% 4/228 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Cardiac arrest	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Cardiac failure acute	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Cardio-respiratory arrest	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Cellulitis	1.1% 1/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Cerebrovascular accident	2.2% 2/90 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.3% 3/228 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Chest pain	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Hepatobiliary disorders Cholecystitis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Colitis	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.3% 3/228 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Confusional state	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Death	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	2.2% 2/90 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.3% 3/228 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	2.2% 2/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.8% 4/228 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Embolic stroke	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Vascular disorders Embolism	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Encephalitis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Encephalopathy	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Exfoliative rash	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.2% 5/228 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Hepatobiliary disorders Gallbladder rupture	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders General physical health deterioration	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Gingivitis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.2% 2/90 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.3% 3/228 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemothorax	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Hallucination	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Hepatobiliary disorders Hepatotoxicity	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Herpes zoster	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Immune system disorders Hypersensitivity	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypertension	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Endocrine disorders Hyperthyroidism	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal neoplasm	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Infusion site extravasation	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Liver function test increased	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Lower respiratory tract infection	3.3% 3/90 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.8% 4/228 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Lymphadenopathy	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Malaise	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.4% 8/52 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	6.6% 15/228 • Number of events 15 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Mucosal inflammation	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Myocardial infarction	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	2.2% 2/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Odynophagia	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Ophthalmic herpes zoster	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Pancreatic enzymes increased	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Pancreatitis acute	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Pancytopenia	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Vascular disorders Peripheral ischaemia	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Platelet count decreased	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 2/90 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.2% 5/228 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	14.0% 12/86 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.7% 4/52 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.2% 21/228 • Number of events 21 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 3/86 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.8% 4/228 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Pyrexia	2.2% 2/90 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Radiation necrosis	1.1% 1/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Sciatica	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Sepsis	3.3% 3/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.8% 4/228 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin ulcer	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Spinal compression fracture	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Stomatitis	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Subdural haemorrhage	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Vascular disorders Superior vena cava syndrome	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Syncope	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Transient ischaemic attack	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Urosepsis	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Vascular device infection	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Vocal cord paralysis	0.00% 0/90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.44% 1/228 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	2.2% 2/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.88% 2/228 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.

Other adverse events

Measure	Pembrolizumab + Chemotherapy + Epacadostat n=90 participants at risk Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Chemotherapy + Placebo n=86 participants at risk Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).	Pembrolizumab + Epacadostat n=52 participants at risk Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.	Total n=228 participants at risk Total
Endocrine disorders Hyperthyroidism	6.7% 6/90 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 6/86 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 3/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	6.6% 15/228 • Number of events 17 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Hypoaesthesia	7.8% 7/90 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.1% 7/86 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	6.1% 14/228 • Number of events 15 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	1.1% 1/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 5/86 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.6% 6/228 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	10.0% 9/90 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.3% 8/86 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.9% 18/228 • Number of events 26 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	8.9% 8/90 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.1% 7/86 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 16/228 • Number of events 23 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	4.4% 4/90 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 6/86 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.8% 11/228 • Number of events 16 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Endocrine disorders Hypothyroidism	11.1% 10/90 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	10.5% 9/86 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	13.5% 7/52 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.4% 26/228 • Number of events 27 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	17.8% 16/90 • Number of events 16 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.1% 7/86 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.0% 25/228 • Number of events 25 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Eye disorders Lacrimation increased	12.2% 11/90 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.3% 8/86 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.3% 19/228 • Number of events 21 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Leukopenia	6.7% 6/90 • Number of events 25 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.7% 4/86 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.4% 10/228 • Number of events 32 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Lipase increased	7.8% 7/90 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 6/86 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.6% 5/52 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.9% 18/228 • Number of events 21 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Mucosal inflammation	5.6% 5/90 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.1% 7/86 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.3% 12/228 • Number of events 15 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	6.7% 6/90 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 3/86 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.6% 5/52 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	6.1% 14/228 • Number of events 16 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	3.3% 3/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.1% 7/86 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.4% 10/228 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	4.4% 4/90 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 6/86 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.4% 10/228 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	16.7% 15/90 • Number of events 20 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.6% 10/86 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.4% 26/228 • Number of events 35 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	12.2% 11/90 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	18.6% 16/86 • Number of events 16 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.8% 27/228 • Number of events 27 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Amylase increased	11.1% 10/90 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.6% 10/86 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	13.5% 7/52 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.8% 27/228 • Number of events 32 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	26.7% 24/90 • Number of events 34 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	43.0% 37/86 • Number of events 56 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.4% 8/52 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	30.3% 69/228 • Number of events 101 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Anxiety	3.3% 3/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 5/86 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.4% 10/228 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	15.6% 14/90 • Number of events 21 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.6% 10/86 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.6% 5/52 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	12.7% 29/228 • Number of events 39 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Aspartate aminotransferase increased	16.7% 15/90 • Number of events 22 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.3% 8/86 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 3/52 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.4% 26/228 • Number of events 37 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Asthenia	13.3% 12/90 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	20.9% 18/86 • Number of events 24 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.5% 6/52 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.8% 36/228 • Number of events 47 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	15.6% 14/90 • Number of events 18 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.6% 10/86 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.4% 8/52 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	14.0% 32/228 • Number of events 37 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Blood alkaline phosphatase increased	7.8% 7/90 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 3/86 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.3% 12/228 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Blood creatinine increased	7.8% 7/90 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.1% 7/86 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.7% 4/52 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.9% 18/228 • Number of events 23 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Bone pain	5.6% 5/90 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 3/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 8/228 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Chest pain	3.3% 3/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.1% 13/86 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	19.2% 10/52 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.4% 26/228 • Number of events 27 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	28.9% 26/90 • Number of events 40 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	26.7% 23/86 • Number of events 35 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.4% 8/52 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	25.0% 57/228 • Number of events 84 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 10/90 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	12.8% 11/86 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	23.1% 12/52 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	14.5% 33/228 • Number of events 37 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	21.1% 19/90 • Number of events 23 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	23.3% 20/86 • Number of events 23 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.4% 8/52 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	20.6% 47/228 • Number of events 57 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	4.4% 4/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 3/52 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.9% 9/228 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	25.6% 23/90 • Number of events 36 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	26.7% 23/86 • Number of events 35 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	26.9% 14/52 • Number of events 19 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	26.3% 60/228 • Number of events 90 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	17.8% 16/90 • Number of events 17 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.1% 13/86 • Number of events 17 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.6% 5/52 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	14.9% 34/228 • Number of events 41 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Dry mouth	1.1% 1/90 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 5/86 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.6% 6/228 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Dysgeusia	8.9% 8/90 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 5/86 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.7% 13/228 • Number of events 15 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	6.7% 6/90 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 3/52 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.4% 10/228 • Number of events 18 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Dysphagia	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.7% 4/86 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.9% 9/228 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.3% 12/90 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	12.8% 11/86 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	13.5% 7/52 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	13.2% 30/228 • Number of events 32 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.8% 7/90 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 6/86 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	6.1% 14/228 • Number of events 16 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Fall	3.3% 3/90 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 5/86 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.9% 9/228 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Fatigue	31.1% 28/90 • Number of events 40 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	29.1% 25/86 • Number of events 32 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	26.9% 14/52 • Number of events 16 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	29.4% 67/228 • Number of events 88 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Gamma-glutamyltransferase increased	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.1% 7/86 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 3/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	6.6% 15/228 • Number of events 20 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.4% 4/90 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	8.1% 7/86 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 3/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	6.1% 14/228 • Number of events 16 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Headache	15.6% 14/90 • Number of events 18 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	12.8% 11/86 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.6% 5/52 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	13.2% 30/228 • Number of events 38 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypercalcaemia	5.6% 5/90 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.1% 7/228 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	4.4% 4/90 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 6/86 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.3% 12/228 • Number of events 17 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Vascular disorders Hypertension	5.6% 5/90 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 3/86 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 8/228 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	6.7% 6/90 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 3/86 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.8% 11/228 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 3/86 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.4% 10/228 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	5.6% 5/90 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 5/86 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 3/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.7% 13/228 • Number of events 20 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	42.2% 38/90 • Number of events 80 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	43.0% 37/86 • Number of events 101 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	19.2% 10/52 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	37.3% 85/228 • Number of events 194 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 8/228 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Neuropathy peripheral	15.6% 14/90 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.6% 10/86 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.0% 25/228 • Number of events 26 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	17.8% 16/90 • Number of events 24 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	17.4% 15/86 • Number of events 25 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	14.5% 33/228 • Number of events 52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Neutrophil count decreased	4.4% 4/90 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	16.3% 14/86 • Number of events 20 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.9% 18/228 • Number of events 28 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Oedema peripheral	15.6% 14/90 • Number of events 20 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.6% 10/86 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.7% 4/52 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	12.3% 28/228 • Number of events 35 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 8/228 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	12.2% 11/90 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.8% 5/86 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.9% 18/228 • Number of events 20 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Nervous system disorders Paraesthesia	6.7% 6/90 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.1% 7/228 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Peripheral swelling	6.7% 6/90 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.9% 9/228 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Platelet count decreased	5.6% 5/90 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	10.5% 9/86 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	6.1% 14/228 • Number of events 21 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	7.8% 7/90 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.4% 10/228 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 2/90 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 6/86 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.5% 8/228 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.2% 1/86 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.7% 4/52 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.4% 10/228 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	13.3% 12/90 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	12.8% 11/86 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.5% 6/52 • Number of events 11 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	12.7% 29/228 • Number of events 38 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
General disorders Pyrexia	16.7% 15/90 • Number of events 21 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.6% 10/86 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	17.3% 9/52 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	14.9% 34/228 • Number of events 46 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	24.4% 22/90 • Number of events 35 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	20.9% 18/86 • Number of events 25 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	19.2% 10/52 • Number of events 13 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	21.9% 50/228 • Number of events 73 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.6% 5/90 • Number of events 5 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.1% 7/228 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	11.1% 10/90 • Number of events 12 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/86 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.8% 2/52 • Number of events 2 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	5.3% 12/228 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	10.0% 9/90 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	4.8% 11/228 • Number of events 17 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	12.2% 11/90 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.0% 6/86 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	1.9% 1/52 • Number of events 1 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.9% 18/228 • Number of events 22 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	5.6% 5/90 • Number of events 8 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	10.5% 9/86 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.7% 4/52 • Number of events 4 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	7.9% 18/228 • Number of events 22 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Infections and infestations Viral infection	5.6% 5/90 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	2.3% 2/86 • Number of events 3 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	0.00% 0/52 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	3.1% 7/228 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	21.1% 19/90 • Number of events 29 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	12.8% 11/86 • Number of events 14 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.5% 6/52 • Number of events 6 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	15.8% 36/228 • Number of events 49 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.
Investigations Weight decreased	11.1% 10/90 • Number of events 10 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	9.3% 8/86 • Number of events 9 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	13.5% 7/52 • Number of events 7 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.	11.0% 25/228 • Number of events 26 • Up to 25 months All participants as treated (APaT) population included all randomized participants who received at least one dose of study treatment.

Additional Information

Study Director

Incyte Corporation

Phone: 855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Clinical Study Agreement
• Publication restrictions are in place

Restriction type: OTHER