A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemothe... | NCT02775435

ID	Type	Description
173568	Registry Identifier	JAPIC-CTI
MK-3475-407	Other Identifier	MSD Protocol Number
KEYNOTE-407	Other Identifier	MSD
2016-000229-38	EudraCT Number

Label	Type	Description	Intervention Names
Pembrolizumab + Chemotherapy Combo	Experimental	Participants receive pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin area under the curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Biological: Pembrolizumab Drug: Paclitaxel Drug: Nab-paclitaxel Drug: Carboplatin
Placebo + Chemotherapy	Active Comparator	Participants receive normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Drug: Paclitaxel Drug: Nab-paclitaxel Drug: Carboplatin Drug: Saline placebo for pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Pembrolizumab + Chemotherapy Combo

Measure	Description	Time Frame
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	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 Response Criteria in Solid Tumors version 1.1 (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 ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 is presented.	Up to approximately 19 months
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. OS is presented.	Up to approximately 19 months

Measure	Description	Time Frame
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR as assessed by blinded independent central review per RECIST 1.1 is presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer [AJCC] 7th edition) squamous NSCLC.
Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
Has not received prior systemic treatment for metastatic NSCLC.
Has provided tumor tissue from locations not radiated prior to biopsy.
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 an adequate method of contraception for the course of the study through 180 days after the last dose of study drug.
If male with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception starting with the first dose of study drug through 95 days after the last dose of study drug. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.

Exclusion Criteria:

Has non-squamous 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 drug: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease; b) Has received other targeted or biological antineoplastic therapy (e.g., erlotinib, crizotinib, cetuximab) for metastatic disease; c) Has had major surgery (<3 weeks prior to first dose).
Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study drug.
Completed palliative radiotherapy within 7 days of the first dose of study drug.
Is expected to require any other form of antineoplastic therapy while on study.
Has received a live-virus vaccination within 30 days of planned treatment start.
Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has pre-existing peripheral neuropathy that is ≥ Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.
Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody.
Has a known sensitivity to any component of carboplatin or paclitaxel or nab-paclitaxel.
Has active autoimmune disease that has required systemic treatment in past 2 years.
Is on chronic systemic steroids.
Had prior treatment with any other anti-programmed cell death 1 (anti-PD-1), or programmed cell death ligand 1 (PD-L1) or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms.
Has participated in any other pembrolizumab trial 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. Active Hepatitis B.
Is, at the time of providing documented informed consent, a regular user (including "recreational use") of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol).
Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.

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 + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (~ 1 year additional).

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	Jul 25, 2022

ID	Title	Description
BG000	Pembrolizumab + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (~ 1 year additional).
BG001	Placebo + Chemotherapy	Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (~ 1 year additional).
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000278 BG001281 BG002559

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) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

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 Response Criteria in Solid Tumors version 1.1 (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 ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 is presented.

The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 19 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (~ 1 year additional).
OG001	Placebo + Chemotherapy	Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (~ 1 year additional).

Units	Counts
Participants	OG000278 OG001281

Title

Denominators

Categories

Title	Measurements
	OG0006.4(6.2 to 8.3) OG0014.8(4.3 to 5.7)

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		Regression, Cox		<0.0001	Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score [TPS] ≥1% vs. <1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) & geographic region (East Asia vs. non-East Asia)	Hazard Ratio (HR)	0.56			2-Sided	95	0.45	0.70					Superiority

Primary

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. OS is presented.

Posted

Median

95% Confidence Interval

Months

Up to approximately 19 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (~ 1 year additional).
OG001	Placebo + Chemotherapy	Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (~ 1 year additional).

Secondary

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR as assessed by blinded independent central review per RECIST 1.1 is presented.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 19 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (~ 1 year additional).
OG001

Secondary

Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 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 CR or PR until disease progression as assessed by RECIST 1.1 or death. DOR as assessed by blinded independent central review per RECIST 1.1 is presented.

The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.

Posted

Median

Full Range

Months

Up to approximately 19 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (~ 1 year additional).

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced an AE is presented.

The Safety population consisted of all participants who received ≥1 dose of study treatment.

Posted

Count of Participants

Participants

Up to approximately 83 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (~ 1 year additional).

Secondary

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

The Safety population consisted of all participants who received ≥1 dose of study treatment.

Posted

Count of Participants

Participants

Up to approximately 29 months

ID	Title	Description
OG000	Pembrolizumab + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (~ 1 year additional).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected278 at risk EG0017 events7 affected280 at risk EG0021 events1 affected118 at risk EG0030 events0 affected12 at risk EG0040 events0 affected1 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00015 events15 affected278 at risk EG00112 events10 affected280 at risk EG0020 events0 affected118 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected278 at risk EG0019 events8 affected280 at risk EG0020 events0 affected118 at risk EG003
Splenic haematoma	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0007 events6 affected278 at risk EG0014 events3 affected280 at risk EG0020 events0 affected118 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0013 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Prinzmetal angina	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0021 events1 affected118 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Hypopituitarism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Cataract	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Autoimmune colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected278 at risk EG0016 events6 affected280 at risk EG0020 events0 affected118 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0013 events3 affected280 at risk EG0020 events0 affected118 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0015 events5 affected280 at risk EG0020 events0 affected118 at risk EG003
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Death	General disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected278 at risk EG0013 events3 affected280 at risk EG0021 events1 affected118 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
General physical health deterioration	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected278 at risk EG0015 events5 affected280 at risk EG0020 events0 affected118 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Amyloidosis	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Appendiceal abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Biliary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Blister infected	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0021 events1 affected118 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Campylobacter colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Candida infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Device related infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Hepatitis B	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Hepatitis E	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Kidney infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Klebsiella infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Large intestine infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Lung abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Meningitis pneumococcal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00023 events22 affected278 at risk EG00123 events21 affected280 at risk EG0029 events7 affected118 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected280 at risk EG0021 events1 affected118 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Prostatic abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected280 at risk EG0021 events1 affected118 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0013 events3 affected280 at risk EG0020 events0 affected118 at risk EG003
Stoma site infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0011 events1 affected280 at risk EG0021 events1 affected118 at risk EG003
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Vascular device infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0021 events1 affected118 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0015 events5 affected280 at risk EG0021 events1 affected118 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0004 events2 affected278 at risk EG0013 events3 affected280 at risk EG0020 events0 affected118 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected280 at risk EG0022 events2 affected118 at risk EG003
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0022 events1 affected118 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0021 events1 affected118 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Carotid artery occlusion	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Intercostal neuralgia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Sciatica	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Seizure	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Uraemic encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Delirium	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0014 events4 affected280 at risk EG0021 events1 affected118 at risk EG003
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0012 events2 affected280 at risk EG0022 events2 affected118 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected278 at risk EG0014 events4 affected280 at risk EG0022 events2 affected118 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected278 at risk EG0013 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events9 affected278 at risk EG0012 events2 affected280 at risk EG0025 events5 affected118 at risk EG003
Pneumonitis aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0013 events3 affected280 at risk EG0020 events0 affected118 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Arterial disorder	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Arterial haemorrhage	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Embolism	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected280 at risk EG0020 events0 affected118 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Superficial vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0021 events1 affected118 at risk EG003
Thrombophlebitis migrans	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected280 at risk EG0020 events0 affected118 at risk EG003
Vasculitis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 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	EG000200 events148 affected278 at risk EG001186 events139 affected280 at risk EG00226 events17 affected118 at risk EG0031 events1 affected12 at risk EG0040 events0 affected1 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00046 events20 affected278 at risk EG00140 events20 affected280 at risk EG0021 events1 affected118 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000201 events99 affected278 at risk EG001166 events85 affected280 at risk EG0020 events0 affected118 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000131 events81 affected278 at risk EG00195 events64 affected280 at risk EG0026 events4 affected118 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG00022 events20 affected278 at risk EG0012 events2 affected280 at risk EG0025 events5 affected118 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG00036 events33 affected278 at risk EG0017 events6 affected280 at risk EG0026 events5 affected118 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00024 events22 affected278 at risk EG00117 events17 affected280 at risk EG0024 events3 affected118 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00093 events70 affected278 at risk EG00174 events62 affected280 at risk EG00214 events12 affected118 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000141 events88 affected278 at risk EG00186 events65 affected280 at risk EG00222 events16 affected118 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00012 events10 affected278 at risk EG0013 events3 affected280 at risk EG0027 events6 affected118 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected278 at risk EG0017 events6 affected280 at risk EG0023 events3 affected118 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000151 events101 affected278 at risk EG001136 events90 affected280 at risk EG00213 events12 affected118 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00017 events14 affected278 at risk EG00116 events15 affected280 at risk EG0022 events2 affected118 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00071 events51 affected278 at risk EG00147 events30 affected280 at risk EG0028 events6 affected118 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG00083 events62 affected278 at risk EG00172 events60 affected280 at risk EG00216 events8 affected118 at risk EG003
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG00021 events20 affected278 at risk EG00124 events24 affected280 at risk EG00210 events9 affected118 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG00092 events67 affected278 at risk EG001102 events72 affected280 at risk EG00215 events15 affected118 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG00027 events26 affected278 at risk EG00130 events22 affected280 at risk EG0024 events3 affected118 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00045 events39 affected278 at risk EG00141 events35 affected280 at risk EG0027 events5 affected118 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected280 at risk EG0021 events1 affected118 at risk EG003
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00025 events22 affected278 at risk EG00112 events11 affected280 at risk EG0025 events5 affected118 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00027 events20 affected278 at risk EG0017 events7 affected280 at risk EG0022 events2 affected118 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00016 events14 affected278 at risk EG00116 events16 affected280 at risk EG0026 events5 affected118 at risk EG003
Stoma site infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00030 events20 affected278 at risk EG00113 events10 affected280 at risk EG0027 events4 affected118 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00017 events16 affected278 at risk EG0019 events8 affected280 at risk EG0027 events7 affected118 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00039 events23 affected278 at risk EG00112 events12 affected280 at risk EG0029 events5 affected118 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00040 events26 affected278 at risk EG00117 events16 affected280 at risk EG0028 events6 affected118 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00019 events12 affected278 at risk EG00112 events12 affected280 at risk EG0025 events4 affected118 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00013 events5 affected278 at risk EG0016 events3 affected280 at risk EG0026 events3 affected118 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00037 events26 affected278 at risk EG00124 events15 affected280 at risk EG00220 events11 affected118 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00059 events24 affected278 at risk EG00160 events28 affected280 at risk EG0020 events0 affected118 at risk EG003
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00052 events25 affected278 at risk EG00142 events23 affected280 at risk EG0021 events1 affected118 at risk EG003
Weight decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00033 events31 affected278 at risk EG00124 events24 affected280 at risk EG00212 events11 affected118 at risk EG003
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00078 events32 affected278 at risk EG00161 events32 affected280 at risk EG0020 events0 affected118 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG000120 events77 affected278 at risk EG001101 events82 affected280 at risk EG00211 events9 affected118 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected278 at risk EG0018 events7 affected280 at risk EG00210 events8 affected118 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00014 events11 affected278 at risk EG00113 events12 affected280 at risk EG0027 events5 affected118 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00021 events15 affected278 at risk EG00119 events12 affected280 at risk EG0028 events7 affected118 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00013 events7 affected278 at risk EG00127 events18 affected280 at risk EG0025 events4 affected118 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00031 events18 affected278 at risk EG00128 events19 affected280 at risk EG00213 events8 affected118 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00036 events24 affected278 at risk EG00127 events21 affected280 at risk EG0024 events4 affected118 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00028 events20 affected278 at risk EG00114 events13 affected280 at risk EG0028 events7 affected118 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0009 events7 affected278 at risk EG00117 events11 affected280 at risk EG0029 events7 affected118 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG000103 events70 affected278 at risk EG00161 events48 affected280 at risk EG00213 events10 affected118 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00024 events24 affected278 at risk EG00138 events37 affected280 at risk EG0027 events7 affected118 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00047 events37 affected278 at risk EG00141 events34 affected280 at risk EG0023 events3 affected118 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00031 events23 affected278 at risk EG00136 events27 affected280 at risk EG0024 events4 affected118 at risk EG003
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00025 events21 affected278 at risk EG00123 events20 affected280 at risk EG0025 events4 affected118 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00027 events24 affected278 at risk EG00111 events11 affected280 at risk EG0022 events2 affected118 at risk EG003
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00028 events25 affected278 at risk EG00127 events23 affected280 at risk EG0029 events4 affected118 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00069 events60 affected278 at risk EG00156 events48 affected280 at risk EG0020 events0 affected118 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00022 events21 affected278 at risk EG00117 events16 affected280 at risk EG0020 events0 affected118 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00034 events33 affected278 at risk EG00139 events37 affected280 at risk EG0020 events0 affected118 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00017 events15 affected278 at risk EG0019 events8 affected280 at risk EG0020 events0 affected118 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00032 events31 affected278 at risk EG00124 events23 affected280 at risk EG0025 events5 affected118 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00055 events49 affected278 at risk EG00166 events56 affected280 at risk EG00213 events12 affected118 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00046 events41 affected278 at risk EG00149 events45 affected280 at risk EG00215 events15 affected118 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00032 events27 affected278 at risk EG00121 events19 affected280 at risk EG0020 events0 affected118 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00024 events23 affected278 at risk EG00136 events25 affected280 at risk EG00214 events12 affected118 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00021 events14 affected278 at risk EG0016 events6 affected280 at risk EG0020 events0 affected118 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00021 events18 affected278 at risk EG00115 events13 affected280 at risk EG0028 events8 affected118 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG000129 events128 affected278 at risk EG001106 events105 affected280 at risk EG0020 events0 affected118 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00012 events12 affected278 at risk EG0018 events8 affected280 at risk EG0021 events1 affected118 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00061 events51 affected278 at risk EG00129 events25 affected280 at risk EG00218 events15 affected118 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00062 events52 affected278 at risk EG00137 events32 affected280 at risk EG0027 events7 affected118 at risk EG003
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0010 events0 affected280 at risk EG0020 events0 affected118 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00022 events18 affected278 at risk EG00115 events14 affected280 at risk EG0023 events3 affected118 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00013 events12 affected278 at risk EG00119 events16 affected280 at risk EG0024 events4 affected118 at risk EG003

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

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
D017239	Paclitaxel
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel
D016190	Carboplatin

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D000418	Albumins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D056831	Coordination Complexes

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembrolizumab + Chemotherapy Combo	Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	225	278	128	278	270	278
EG001	Placebo + Chemotherapy	Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles (~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	143	281	114	280	272	280
EG002	Placebo Switched Over to Pembrolizumab	Participants who received saline placebo with chemotherapy and who experienced disease progression, switched over to receive pembrolizumab monotherapy at investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for 35 cycles (~ 2 years).	111	118	35	118	90	118
EG003	Pembrolizumab Combo (Second Course)	Participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) and were deemed to be benefitting clinically despite progression, received a second course of pembrolizumab at the investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to ~1 year additional).	6	12	2	12	9	12
EG004	Placebo Switched Over to Pembrolizumab (Second Course)	Participants who switched from saline placebo to complete the first course of up to 35 administrations of pembrolizumab (~2 years), initiated a second course of pembrolizumab at investigator's discretion. Pembrolizumab was administered 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to ~1 year).	0	1	0	1	0	1