Study of Pemetrexed+Platinum Chemotherapy With or Without... | NCT02578680

ID	Type	Description
163421	Registry Identifier	JAPIC-CTI
MK-3475-189	Other Identifier	MSD
2015-003694-15	EudraCT Number

Label	Type	Description	Intervention Names
Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Experimental	Participants receive pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who receive pembrolizumab 200 mg IV Q3W for up to 2 years but experience disease progression, will be eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Biological: Pembrolizumab 200 mg Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Dietary Supplement: Folic acid 350-1000 μg Dietary Supplement: Vitamin B12 1000 μg Drug: Dexamethasone 4 mg
Control	Active Comparator	Participants receive saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Effective 23-Dec-2019, participants will discontinue saline placebo. If documented progression occurs, participants may be able to receive pembrolizumab monotherapy Q3W for the remainder of the study.)	Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Dietary Supplement: Folic acid 350-1000 μg Dietary Supplement: Vitamin B12 1000 μg Drug: Dexamethasone 4 mg Drug: Saline solution

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab 200 mg	Biological	IV infusion	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed

Measure	Description	Time Frame
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging	PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 is presented.	Up to approximately 21 months
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS is presented.	Up to approximately 21 months

Measure	Description	Time Frame
Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.

Measure	Description	Time Frame
Progression-Free Survival (PFS) as Assessed by Investigator Immune-related RECIST (irRECIST) Response Criteria	PFS was defined as the time from randomization to the first documented immune-related progressive disease (irPD) or death due to any cause, whichever occurred first. Per irRECIST, irPD was confirmed if any of the following are observed in 2 scans performed at least 4 weeks apart: target lesion sum of diameters remains ≥20 % and at least 5 mm absolute increase compared to nadir; non-target disease resulting in initial PD is qualitatively worse; new lesion resulting in initial irPD is qualitatively worse; additional new lesion(s) since last evaluation; or additional new non-target lesion progression since last evaluation. The PFS per irRECIST 1.1 is presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV nonsquamous NSCLC.
Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
Has measurable disease.
Has not received prior systemic treatment for their advanced/metastatic NSCLC.
Can provide tumor tissue.
Has a life expectancy of at least 3 months.
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Has adequate organ function
If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.

Exclusion Criteria:

Has predominantly squamous cell histology NSCLC.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of pembrolizumab.
Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (<3 weeks prior to first dose)
Received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study medication.
Completed palliative radiotherapy within 7 days of the first dose of study medication.
Is expected to require any other form of antineoplastic therapy while on study.
Received a live-virus vaccination within 30 days of planned start of study medication.
Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis.
Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).
Known sensitivity to any component of cisplatin, carboplatin or pemetrexed.
Has active autoimmune disease that has required systemic treatment in past 2 years.
Is on chronic systemic steroids.
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Is unable or unwilling to take folic acid or vitamin B12 supplementation.
Had prior treatment with any other anti-programmed cell death-1 (PD-1), or PD-ligand 1 (PD-L1) or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Has participated in any other pembrolizumab study and has been treated with pembrolizumab.
Has an active infection requiring therapy.
Has known history of Human Immunodeficiency Virus (HIV).
Has known active Hepatitis B or C.
Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
Is a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
Has symptomatic ascites or pleural effusion.
Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management.
Is pregnant or breastfeeding, or expecting to conceive or father children prior to 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
40498298	Derived	Garassino MC, Cheng Y, Rodriguez-Abreu D, Novello S, Mazieres J, Robinson AG, Powell SF, Halmos B, Gray JE, Wang M, Chen C, Yang J, Souza F, Schwarzenberger P, Paz-Ares L. Impact of Tumor Response and Response Duration on Survival Among Participants Receiving Pembrolizumab Plus Chemotherapy as First-Line Therapy for Non-Small-Cell Lung Cancer. Oncol Ther. 2025 Sep;13(3):667-681. doi: 10.1007/s40487-025-00350-6. Epub 2025 Jun 11.
38642841

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)

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	May 31, 2022

ID	Title	Description
BG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
BG001	Control	Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000410 BG001206 BG002616

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

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 is presented.

The analysis population consisted of all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to approximately 21 months

ID	Title	Description
OG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
OG001	Control	Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)

Units	Counts
Participants	OG000410 OG001206

Title

Denominators

Categories

Title	Measurements
	OG0008.8(7.6 to 9.2) OG0014.9(4.7 to 5.5)

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		Log Rank		<0.00001		Hazard Ratio (HR)	0.52			2-Sided	95	0.43	0.64			Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. <1%), platinum chemotherapy (cisplatin vs. carboplatin) & smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.		Superiority

Primary

Overall Survival (OS)

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

The analysis population consisted of all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to approximately 21 months

ID	Title	Description
OG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
OG001	Control	Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)

Secondary

Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging

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

The analysis population consisted of all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 21 months

ID	Title	Description
OG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
OG001	Control	Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)

Secondary

Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Central Imaging

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.

The analysis population consisted of all randomized participants who experienced a confirmed CR or confirmed PR.

Posted

Median

Full Range

Months

Up to approximately 21 months

ID	Title	Description
OG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug. The number of participants who experienced an AE is presented.

The analysis population consisted of all randomized participants who received ≥1 dose of study drug.

Posted

Count of Participants

Participants

Up to approximately 21 months (Serious AEs: Up to 90 days after last dose of study treatment; Other AEs: Up to 30 days after last dose of study treatment)

ID	Title	Description
OG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
OG001	Control	Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)

Secondary

Number of Participants Who Discontinued Any Study Drug Due to an AE

The analysis population consisted of all randomized participants who received ≥1 dose of study drug.

Posted

Count of Participants

Participants

Up to approximately 21 months

ID	Title	Description
OG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
OG001	Control	Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)

Other Pre-specified

Progression-Free Survival (PFS) as Assessed by Investigator Immune-related RECIST (irRECIST) Response Criteria

PFS was defined as the time from randomization to the first documented immune-related progressive disease (irPD) or death due to any cause, whichever occurred first. Per irRECIST, irPD was confirmed if any of the following are observed in 2 scans performed at least 4 weeks apart: target lesion sum of diameters remains ≥20 % and at least 5 mm absolute increase compared to nadir; non-target disease resulting in initial PD is qualitatively worse; new lesion resulting in initial irPD is qualitatively worse; additional new lesion(s) since last evaluation; or additional new non-target lesion progression since last evaluation. The PFS per irRECIST 1.1 is presented.

The analysis population consisted of all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to approximately 39 months

ID	Title	Description
OG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00014 events13 affected405 at risk EG00112 events11 affected202 at risk EG0020 events0 affected84 at risk EG0030 events0 affected2 at risk EG0040 events0 affected9 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00026 events25 affected405 at risk EG0014 events4 affected202 at risk EG0021 events1 affected84 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00014 events13 affected405 at risk EG0016 events6 affected202 at risk EG0020 events0 affected84 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0013 events3 affected202 at risk EG0020 events0 affected84 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0012 events2 affected202 at risk EG0021 events1 affected84 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Myopericarditis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0021 events1 affected84 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected405 at risk EG0010 events0 affected202 at risk EG0022 events2 affected84 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00016 events14 affected405 at risk EG0018 events5 affected202 at risk EG0020 events0 affected84 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Intussusception	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Lip oedema	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Mesenteric artery embolism	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected405 at risk EG0017 events7 affected202 at risk EG0020 events0 affected84 at risk EG003
Neutropenic colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0022 events1 affected84 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected405 at risk EG0015 events5 affected202 at risk EG0021 events1 affected84 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0021 events1 affected84 at risk EG003
Death	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
General physical health deterioration	General disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected405 at risk EG0013 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Inflammation	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Influenza like illness	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Localised oedema	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Mucosal inflammation	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00010 events9 affected405 at risk EG0015 events5 affected202 at risk EG0021 events1 affected84 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cholangitis sclerosing	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Appendicitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Bacillus bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Bacterial colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0014 events3 affected202 at risk EG0021 events1 affected84 at risk EG003
CNS ventriculitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Diabetic foot infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Empyema	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Encephalitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Endocarditis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Erysipelas	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Folliculitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Infectious pleural effusion	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Kidney infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0014 events4 affected202 at risk EG0020 events0 affected84 at risk EG003
Lung abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Otitis media	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Parotitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Peritonitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pneumococcal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00035 events34 affected405 at risk EG00121 events18 affected202 at risk EG0024 events4 affected84 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0012 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Salmonella bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected405 at risk EG0011 events1 affected202 at risk EG0021 events1 affected84 at risk EG003
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Tuberculosis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Tuberculous pleurisy	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected405 at risk EG0015 events2 affected202 at risk EG0021 events1 affected84 at risk EG003
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected405 at risk EG0011 events1 affected202 at risk EG0021 events1 affected84 at risk EG003
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Post procedural diarrhoea	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Shoulder fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Blood calcium decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
C-reactive protein increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0007 events5 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0021 events1 affected84 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Polydipsia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0012 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Hypertrophic osteoarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Tracheal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Brain stem infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Central nervous system vasculitis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Demyelinating polyneuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Lacunar stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0012 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Seizure	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Device dislocation	Product Issues	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Delirium	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Disorientation	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Major depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Autoimmune nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Prerenal failure	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Balanoposthitis	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Scrotal cyst	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0021 events1 affected84 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events6 affected405 at risk EG0014 events3 affected202 at risk EG0021 events1 affected84 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected405 at risk EG0013 events3 affected202 at risk EG0025 events4 affected84 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00014 events13 affected405 at risk EG0016 events5 affected202 at risk EG0021 events1 affected84 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00013 events13 affected405 at risk EG0015 events5 affected202 at risk EG0021 events1 affected84 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected405 at risk EG0014 events4 affected202 at risk EG0024 events3 affected84 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0014 events4 affected202 at risk EG0020 events0 affected84 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0021 events1 affected84 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Skin sensitisation	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0012 events2 affected202 at risk EG0021 events1 affected84 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Jugular vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Venous occlusion	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000253 events186 affected405 at risk EG001114 events91 affected202 at risk EG0028 events6 affected84 at risk EG0030 events0 affected2 at risk EG0040 events0 affected9 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00044 events26 affected405 at risk EG00118 events13 affected202 at risk EG0020 events0 affected84 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000213 events108 affected405 at risk EG00192 events49 affected202 at risk EG0020 events0 affected84 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000108 events68 affected405 at risk EG00137 events25 affected202 at risk EG0021 events1 affected84 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Otorrhoea	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG00019 events14 affected405 at risk EG00112 events11 affected202 at risk EG0020 events0 affected84 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG00021 events17 affected405 at risk EG0017 events4 affected202 at risk EG0022 events1 affected84 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG00038 events31 affected405 at risk EG0017 events5 affected202 at risk EG0026 events6 affected84 at risk EG003
Dry eye	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00023 events21 affected405 at risk EG0015 events5 affected202 at risk EG0022 events2 affected84 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00087 events75 affected405 at risk EG00124 events22 affected202 at risk EG0021 events1 affected84 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00049 events39 affected405 at risk EG00114 events13 affected202 at risk EG0027 events7 affected84 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00031 events29 affected405 at risk EG0014 events4 affected202 at risk EG0020 events0 affected84 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000220 events143 affected405 at risk EG00187 events67 affected202 at risk EG0027 events7 affected84 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000179 events123 affected405 at risk EG00154 events41 affected202 at risk EG00219 events11 affected84 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00031 events28 affected405 at risk EG00111 events11 affected202 at risk EG0021 events1 affected84 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00018 events17 affected405 at risk EG0016 events6 affected202 at risk EG0022 events2 affected84 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000430 events232 affected405 at risk EG001186 events103 affected202 at risk EG00218 events16 affected84 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00054 events37 affected405 at risk EG00121 events16 affected202 at risk EG0020 events0 affected84 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000183 events104 affected405 at risk EG00170 events43 affected202 at risk EG00214 events12 affected84 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG000158 events85 affected405 at risk EG00174 events47 affected202 at risk EG0028 events6 affected84 at risk EG003
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG00044 events38 affected405 at risk EG00114 events12 affected202 at risk EG0026 events6 affected84 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG000285 events173 affected405 at risk EG001127 events80 affected202 at risk EG0029 events8 affected84 at risk EG003
Mucosal inflammation	General disorders	MedDRA 26.0	Systematic Assessment	EG00048 events37 affected405 at risk EG00124 events16 affected202 at risk EG0021 events1 affected84 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG000180 events103 affected405 at risk EG00148 events35 affected202 at risk EG00211 events11 affected84 at risk EG003
Pain	General disorders	MedDRA 26.0	Systematic Assessment	EG00022 events22 affected405 at risk EG0017 events7 affected202 at risk EG0021 events1 affected84 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG000118 events84 affected405 at risk EG00147 events30 affected202 at risk EG0027 events6 affected84 at risk EG003
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00029 events23 affected405 at risk EG0017 events6 affected202 at risk EG0022 events2 affected84 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00048 events37 affected405 at risk EG00133 events18 affected202 at risk EG0020 events0 affected84 at risk EG003
Ear infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00012 events11 affected405 at risk EG0012 events2 affected202 at risk EG0022 events2 affected84 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00076 events47 affected405 at risk EG00112 events10 affected202 at risk EG0026 events5 affected84 at risk EG003
Otitis externa	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00029 events21 affected405 at risk EG0016 events6 affected202 at risk EG0022 events2 affected84 at risk EG003
Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00012 events10 affected405 at risk EG0011 events1 affected202 at risk EG0023 events2 affected84 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00059 events44 affected405 at risk EG00117 events16 affected202 at risk EG0021 events1 affected84 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00047 events34 affected405 at risk EG00117 events13 affected202 at risk EG0026 events4 affected84 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected405 at risk EG0011 events1 affected202 at risk EG0020 events0 affected84 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00063 events50 affected405 at risk EG00123 events19 affected202 at risk EG0024 events4 affected84 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00057 events40 affected405 at risk EG00116 events13 affected202 at risk EG0026 events5 affected84 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00021 events16 affected405 at risk EG00111 events9 affected202 at risk EG0022 events2 affected84 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00097 events58 affected405 at risk EG00129 events17 affected202 at risk EG00210 events4 affected84 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0014 events4 affected202 at risk EG0020 events0 affected84 at risk EG003
Tri-iodothyronine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Weight decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00059 events44 affected405 at risk EG00117 events16 affected202 at risk EG0024 events4 affected84 at risk EG003
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00057 events28 affected405 at risk EG00120 events13 affected202 at risk EG0020 events0 affected84 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG000172 events122 affected405 at risk EG00181 events63 affected202 at risk EG00219 events17 affected84 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00049 events34 affected405 at risk EG00110 events7 affected202 at risk EG0022 events2 affected84 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00091 events51 affected405 at risk EG00120 events16 affected202 at risk EG0022 events2 affected84 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00054 events37 affected405 at risk EG00114 events8 affected202 at risk EG0020 events0 affected84 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00038 events24 affected405 at risk EG00113 events5 affected202 at risk EG0021 events1 affected84 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00099 events70 affected405 at risk EG00133 events28 affected202 at risk EG00212 events10 affected84 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00086 events71 affected405 at risk EG00129 events26 affected202 at risk EG0027 events7 affected84 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00023 events19 affected405 at risk EG0017 events7 affected202 at risk EG0022 events2 affected84 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00013 events10 affected405 at risk EG0019 events8 affected202 at risk EG0021 events1 affected84 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00016 events16 affected405 at risk EG0018 events6 affected202 at risk EG0024 events4 affected84 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00047 events37 affected405 at risk EG00118 events18 affected202 at risk EG0027 events6 affected84 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00064 events58 affected405 at risk EG00127 events22 affected202 at risk EG0022 events2 affected84 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00041 events36 affected405 at risk EG00117 events17 affected202 at risk EG0021 events1 affected84 at risk EG003
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00072 events57 affected405 at risk EG00129 events22 affected202 at risk EG0027 events5 affected84 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00033 events24 affected405 at risk EG00121 events14 affected202 at risk EG0021 events1 affected84 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00035 events31 affected405 at risk EG00117 events17 affected202 at risk EG0021 events1 affected84 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected405 at risk EG0010 events0 affected202 at risk EG0020 events0 affected84 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG000139 events104 affected405 at risk EG00171 events62 affected202 at risk EG00213 events9 affected84 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG000118 events97 affected405 at risk EG00159 events51 affected202 at risk EG00220 events15 affected84 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00035 events29 affected405 at risk EG00111 events7 affected202 at risk EG0020 events0 affected84 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00016 events14 affected405 at risk EG00120 events16 affected202 at risk EG0022 events2 affected84 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00033 events27 affected405 at risk EG0016 events6 affected202 at risk EG0021 events1 affected84 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00033 events27 affected405 at risk EG00110 events9 affected202 at risk EG0024 events3 affected84 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00028 events25 affected405 at risk EG00110 events10 affected202 at risk EG0021 events1 affected84 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00011 events10 affected405 at risk EG0012 events2 affected202 at risk EG0021 events1 affected84 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00024 events22 affected405 at risk EG00110 events10 affected202 at risk EG0020 events0 affected84 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00028 events27 affected405 at risk EG00122 events20 affected202 at risk EG0021 events1 affected84 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00038 events30 affected405 at risk EG0015 events4 affected202 at risk EG0023 events3 affected84 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00080 events59 affected405 at risk EG00125 events23 affected202 at risk EG0024 events4 affected84 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG000131 events89 affected405 at risk EG00136 events27 affected202 at risk EG0024 events4 affected84 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected405 at risk EG0012 events2 affected202 at risk EG0020 events0 affected84 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00025 events23 affected405 at risk EG00114 events11 affected202 at risk EG0026 events5 affected84 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00027 events24 affected405 at risk EG0014 events4 affected202 at risk EG0021 events1 affected84 at risk EG003

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C582435	pembrolizumab
D002945	Cisplatin
D016190	Carboplatin
D000068437	Pemetrexed
D005492	Folic Acid
D014805	Vitamin B 12
D003907	Dexamethasone
D000077330	Saline Solution

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D011622	Pterins
D011621	Pteridines
D045728	Corrinoids
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D013259	Steroids, Fluorinated
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed	Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	330	410	233	405	395	405
EG001	Control	Participants received saline placebo IV PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)	113	206	102	202	196	202
EG002	Control Switched Over to Pembrolizumab Monotherapy	Qualified participants who received saline placebo with pemetrexed and platinum chemotherapy followed by placebo and pemetrexed, and who experienced disease progression, were switched over to receive pembrolizumab monotherapy 200 mg IV on Day 1 Q3W for up to 2 years.	74	84	29	84	64	84
EG003	Control Switched Over to Pembrolizumab Monotherapy (Second Course)	Participants who were switched from saline placebo to receive pembrolizumab monotherapy, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.	1	2	0	2	2	2
EG004	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (Second Course)	Participants who received pembrolizumab PLUS pemetrexed and platinum chemotherapy followed by pembrolizumab PLUS pemetrexed during the initial treatment but experienced disease progression, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.	4	9	2	9	9	9