A Study of Pembrolizumab Plus Epacadostat With Platinum-b... | NCT03322566

NCT03322566

ID	Type	Description	Link
2017-001810-27	EudraCT Number

Status Module

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pembrolizumab + Chemotherapy + Epacadostat	Experimental	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).	Drug: Pembrolizumab Drug: Epacadostat Drug: Platinum-based chemotherapy
Pembrolizumab + Chemotherapy + Placebo	Experimental	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).	Drug: Pembrolizumab Drug: Platinum-based chemotherapy Drug: Placebo
Pembrolizumab + Epacadostat	Experimental	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.	Drug: Pembrolizumab Drug: Epacadostat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Drug	Pembrolizumab administered intravenously every 3 weeks.	Pembrolizumab + Chemotherapy + Epacadostat Pembrolizumab + Chemotherapy + Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo	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).	Assessed every 12 weeks up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo	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.	Up to 24 months

Eligibility Module

Name	Affiliation	Role
Lance Leopold, MD	Incyte Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southern Cancer Center, PC		Daphne	Alabama	36526	United States
Western Regional Medical Center, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39054462	Derived	Boyer M, Hui R, Urban D, Clingan P, Su WC, Devaux C, Gadgeel S, Garassino M, Leopold L, Daniel J, Munteanu MC, Samkari A, Luo Y, Abreu DR. Pembrolizumab with platinum-based chemotherapy with or without epacadostat as first-line treatment for metastatic non-small cell lung cancer: a randomized, partially double-blind, placebo-controlled phase II study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1250. doi: 10.1186/s12885-022-10427-4.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 4, 2019

Arm/Group Information

ID	Title	Description
BG000	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).
BG001	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).
BG002	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.0± 11.7 BG00163.6± 8.8 BG00262.8± 8.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033 BG00130 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
American Indian Or Alaska Native	BG0001 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Ethnicity

Title	Measurements
Hispanic or Latino	BG0003 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

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).

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.

Posted

Number

95% Confidence Interval

percentage of participants

Assessed every 12 weeks up to 24 months

ID	Title	Description
OG000	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).
OG001	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).

Units	Counts
Participants	OG00091 OG00187

Title

Denominators

Categories

Title	Measurements
	OG00026.4(17.7 to 36.7) OG00144.8(34.1 to 55.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Stratified Miettinen and Nurminen method		0.9948	One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % > 0.	Difference in Percentages	-18.5			2-Sided	95	-32.0	-4.3			Stratified by PD-L1 TPS ( <50% vs. >=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata 'TPS >= 50 percent Non-squamous' and 'TPS >= 50% Squamous' were combined into one stratum.		Superiority

Secondary

Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

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.

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.

Posted

Median

95% Confidence Interval

months

Up to 24 months

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

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

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.

Posted

Median

95% Confidence Interval

months

Up to 24 months

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

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.

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.

Posted

Median

95% Confidence Interval

months

Up to 24 months

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)

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.

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.

Posted

Count of Participants

Participants

Up to 25 months

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs

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.

Posted

Count of Participants

Participants

Up to 25 months

ID	Title	Description
OG000	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).
OG001	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).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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).	38	90	47	90	87	90
EG001	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).	35	86	41	86	81	86
EG002	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.	26	52	20	52	51	52
EG003	Total	Total	99	228	108	228	219	228

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG0031 events1 affected228 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0021 events1 affected52 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Agitation	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0012 events2 affected86 at risk EG0020 events0 affected52 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Breakthrough pain	General disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0003 events3 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0012 events2 affected86 at risk EG0020 events0 affected52 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0003 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Chest pain	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0012 events2 affected86 at risk EG0021 events1 affected52 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Death	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0022 events2 affected52 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0021 events1 affected52 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0003 events2 affected90 at risk EG0012 events2 affected86 at risk EG0020 events0 affected52 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Embolism	Vascular disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Encephalitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Gallbladder rupture	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
General physical health deterioration	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Gingivitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Hypertension	Vascular disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Hypopharyngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Infusion site extravasation	General disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Liver function test increased	Investigations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG0004 events3 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Malaise	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG0012 events2 affected86 at risk EG0028 events8 affected52 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Mucosal inflammation	General disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG0003 events2 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Ophthalmic herpes zoster	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Pancreatic enzymes increased	Investigations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Platelet count decreased	Investigations	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected90 at risk EG0011 events1 affected86 at risk EG0022 events2 affected52 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG00112 events12 affected86 at risk EG0024 events4 affected52 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0013 events3 affected86 at risk EG0020 events0 affected52 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Pyrexia	General disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Radiation necrosis	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0003 events1 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Sciatica	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Sepsis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0003 events3 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Syncope	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0021 events1 affected52 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Urosepsis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Vascular device infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003
Vocal cord paralysis	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected86 at risk EG0021 events1 affected52 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0003 events2 affected90 at risk EG0010 events0 affected86 at risk EG0020 events0 affected52 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0008 events6 affected90 at risk EG0013 events3 affected86 at risk EG0025 events5 affected52 at risk EG00316 events14 affected228 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0003 events3 affected90 at risk EG0018 events7 affected86 at risk EG0020 events0 affected52 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23	Systematic Assessment	EG0004 events4 affected90 at risk EG0016 events6 affected86 at risk EG0020 events0 affected52 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23	Systematic Assessment	EG00020 events15 affected90 at risk EG00112 events10 affected86 at risk EG0023 events1 affected52 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG00011 events11 affected90 at risk EG00116 events16 affected86 at risk EG0020 events0 affected52 at risk EG003
Amylase increased	Investigations	MedDRA 23	Systematic Assessment	EG00014 events10 affected90 at risk EG00110 events10 affected86 at risk EG0028 events7 affected52 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG00034 events24 affected90 at risk EG00156 events37 affected86 at risk EG00211 events8 affected52 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG0003 events3 affected90 at risk EG0015 events5 affected86 at risk EG0022 events2 affected52 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG00021 events14 affected90 at risk EG00113 events10 affected86 at risk EG0025 events5 affected52 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23	Systematic Assessment	EG00022 events15 affected90 at risk EG00110 events8 affected86 at risk EG0025 events3 affected52 at risk EG003
Asthenia	General disorders	MedDRA 23	Systematic Assessment	EG00014 events12 affected90 at risk EG00124 events18 affected86 at risk EG0029 events6 affected52 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG00018 events14 affected90 at risk EG00110 events10 affected86 at risk EG0029 events8 affected52 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 23	Systematic Assessment	EG0007 events7 affected90 at risk EG0014 events3 affected86 at risk EG0022 events2 affected52 at risk EG003
Blood creatinine increased	Investigations	MedDRA 23	Systematic Assessment	EG0008 events7 affected90 at risk EG00111 events7 affected86 at risk EG0024 events4 affected52 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0008 events5 affected90 at risk EG0010 events0 affected86 at risk EG0023 events3 affected52 at risk EG003
Chest pain	General disorders	MedDRA 23	Systematic Assessment	EG0003 events3 affected90 at risk EG00113 events13 affected86 at risk EG00211 events10 affected52 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00040 events26 affected90 at risk EG00135 events23 affected86 at risk EG0029 events8 affected52 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG00010 events10 affected90 at risk EG00113 events11 affected86 at risk EG00214 events12 affected52 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG00023 events19 affected90 at risk EG00123 events20 affected86 at risk EG00211 events8 affected52 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0005 events4 affected90 at risk EG0012 events2 affected86 at risk EG0026 events3 affected52 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00036 events23 affected90 at risk EG00135 events23 affected86 at risk EG00219 events14 affected52 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23	Systematic Assessment	EG00017 events16 affected90 at risk EG00117 events13 affected86 at risk EG0027 events5 affected52 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected90 at risk EG0015 events5 affected86 at risk EG0020 events0 affected52 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0009 events8 affected90 at risk EG0016 events5 affected86 at risk EG0020 events0 affected52 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00011 events6 affected90 at risk EG0012 events1 affected86 at risk EG0025 events3 affected52 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG0014 events4 affected86 at risk EG0020 events0 affected52 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG00014 events12 affected90 at risk EG00111 events11 affected86 at risk EG0027 events7 affected52 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0007 events7 affected90 at risk EG0018 events6 affected86 at risk EG0021 events1 affected52 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0003 events3 affected90 at risk EG0016 events5 affected86 at risk EG0021 events1 affected52 at risk EG003
Fatigue	General disorders	MedDRA 23	Systematic Assessment	EG00040 events28 affected90 at risk EG00132 events25 affected86 at risk EG00216 events14 affected52 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG00112 events7 affected86 at risk EG0023 events3 affected52 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0004 events4 affected90 at risk EG0019 events7 affected86 at risk EG0023 events3 affected52 at risk EG003
Headache	Nervous system disorders	MedDRA 23	Systematic Assessment	EG00018 events14 affected90 at risk EG00113 events11 affected86 at risk EG0027 events5 affected52 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0006 events5 affected90 at risk EG0011 events1 affected86 at risk EG0021 events1 affected52 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0006 events4 affected90 at risk EG0016 events6 affected86 at risk EG0025 events2 affected52 at risk EG003
Hypertension	Vascular disorders	MedDRA 23	Systematic Assessment	EG0007 events5 affected90 at risk EG0014 events3 affected86 at risk EG0020 events0 affected52 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 23	Systematic Assessment	EG0008 events6 affected90 at risk EG0016 events6 affected86 at risk EG0023 events3 affected52 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0007 events7 affected90 at risk EG0018 events7 affected86 at risk EG0020 events0 affected52 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0003 events1 affected90 at risk EG0016 events5 affected86 at risk EG0020 events0 affected52 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG00013 events9 affected90 at risk EG00112 events8 affected86 at risk EG0021 events1 affected52 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG00012 events8 affected90 at risk EG00110 events7 affected86 at risk EG0021 events1 affected52 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG0004 events4 affected90 at risk EG00111 events6 affected86 at risk EG0021 events1 affected52 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 23	Systematic Assessment	EG00010 events10 affected90 at risk EG0019 events9 affected86 at risk EG0028 events7 affected52 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG00016 events16 affected90 at risk EG0017 events7 affected86 at risk EG0022 events2 affected52 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 23	Systematic Assessment	EG00013 events11 affected90 at risk EG0018 events8 affected86 at risk EG0020 events0 affected52 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG00025 events6 affected90 at risk EG0017 events4 affected86 at risk EG0020 events0 affected52 at risk EG003
Lipase increased	Investigations	MedDRA 23	Systematic Assessment	EG0009 events7 affected90 at risk EG0017 events6 affected86 at risk EG0025 events5 affected52 at risk EG003
Mucosal inflammation	General disorders	MedDRA 23	Systematic Assessment	EG0007 events5 affected90 at risk EG0018 events7 affected86 at risk EG0020 events0 affected52 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0006 events6 affected90 at risk EG0013 events3 affected86 at risk EG0023 events2 affected52 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG0013 events3 affected86 at risk EG0022 events2 affected52 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0008 events5 affected90 at risk EG0019 events5 affected86 at risk EG0023 events3 affected52 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00080 events38 affected90 at risk EG001101 events37 affected86 at risk EG00213 events10 affected52 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG0012 events2 affected86 at risk EG0021 events1 affected52 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 23	Systematic Assessment	EG00014 events14 affected90 at risk EG00110 events10 affected86 at risk EG0022 events1 affected52 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG00024 events16 affected90 at risk EG00125 events15 affected86 at risk EG0023 events2 affected52 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 23	Systematic Assessment	EG0008 events4 affected90 at risk EG00120 events14 affected86 at risk EG0020 events0 affected52 at risk EG003
Oedema peripheral	General disorders	MedDRA 23	Systematic Assessment	EG00020 events14 affected90 at risk EG00111 events10 affected86 at risk EG0024 events4 affected52 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG0012 events2 affected86 at risk EG0021 events1 affected52 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG00012 events11 affected90 at risk EG0015 events5 affected86 at risk EG0023 events2 affected52 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0006 events6 affected90 at risk EG0011 events1 affected86 at risk EG0020 events0 affected52 at risk EG003
Peripheral swelling	General disorders	MedDRA 23	Systematic Assessment	EG0009 events6 affected90 at risk EG0013 events2 affected86 at risk EG0021 events1 affected52 at risk EG003
Platelet count decreased	Investigations	MedDRA 23	Systematic Assessment	EG0009 events5 affected90 at risk EG00112 events9 affected86 at risk EG0020 events0 affected52 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23	Systematic Assessment	EG0007 events7 affected90 at risk EG0011 events1 affected86 at risk EG0022 events2 affected52 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected90 at risk EG0017 events6 affected86 at risk EG0020 events0 affected52 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG0011 events1 affected86 at risk EG0024 events4 affected52 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG00013 events12 affected90 at risk EG00114 events11 affected86 at risk EG00211 events6 affected52 at risk EG003
Pyrexia	General disorders	MedDRA 23	Systematic Assessment	EG00021 events15 affected90 at risk EG00112 events10 affected86 at risk EG00213 events9 affected52 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG00035 events22 affected90 at risk EG00125 events18 affected86 at risk EG00213 events10 affected52 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23	Systematic Assessment	EG0005 events5 affected90 at risk EG0012 events2 affected86 at risk EG0020 events0 affected52 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG00012 events10 affected90 at risk EG0010 events0 affected86 at risk EG0022 events2 affected52 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23	Systematic Assessment	EG00014 events9 affected90 at risk EG0013 events2 affected86 at risk EG0020 events0 affected52 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG00014 events11 affected90 at risk EG0017 events6 affected86 at risk EG0021 events1 affected52 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG0008 events5 affected90 at risk EG00110 events9 affected86 at risk EG0024 events4 affected52 at risk EG003
Viral infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG0006 events5 affected90 at risk EG0013 events2 affected86 at risk EG0020 events0 affected52 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00029 events19 affected90 at risk EG00114 events11 affected86 at risk EG0026 events6 affected52 at risk EG003
Weight decreased	Investigations	MedDRA 23	Systematic Assessment	EG00010 events10 affected90 at risk EG0019 events8 affected86 at risk EG0027 events7 affected52 at risk EG003

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms

ID	Term
C582435	pembrolizumab
C000613752	epacadostat
D017671	Platinum Compounds