A Study of Aflibercept Administered in Combination With P... | NCT00794417

ID	Type	Description	Link
TCD10767

Name	Class
Sanofi	INDUSTRY

Label	Type	Description	Intervention Names
Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Experimental	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.	Drug: Aflibercept Drug: Pemetrexed Drug: Cisplatin
Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Experimental	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.	Drug: Aflibercept Drug: Pemetrexed Drug: Cisplatin
Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Experimental	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.	Drug: Aflibercept Drug: Pemetrexed Drug: Cisplatin
Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Experimental

Name	Type	Description	Arm Group Labels	Other Names
Aflibercept	Drug	Administered in combination with the other two interventions via intravenous infusion.	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin

Measure	Description	Time Frame
Phase 1: Recommended Dose of Aflibercept for Phase 2	Recommended Dose was defined as the highest combination dose at which fewer than 33 percent (%) of participants experienced dose limiting toxicity during the first cycle of therapy.	Phase 1: Baseline up to 315 Days

Measure	Description	Time Frame
Phase 2: Objective Response Rate	Objective response rate was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as assessed by modified Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the Baseline sum LD as reference.

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Cancer Institute, LLC		Tucson	Arizona	85715	United States
University of Arkansas for Medical Science

PubMed Identifier	Type	Citation	Retractions
22805331	Result	Diaz-Padilla I, Siu LL, San Pedro-Salcedo M, Razak AR, Colevas AD, Shepherd FA, Leighl NB, Neal JW, Thibault A, Liu L, Lisano J, Gao B, Lawson EB, Wakelee HA. A phase I dose-escalation study of aflibercept administered in combination with pemetrexed and cisplatin in patients with advanced solid tumours. Br J Cancer. 2012 Aug 7;107(4):604-11. doi: 10.1038/bjc.2012.319. Epub 2012 Jul 17.
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ID	Title	Description
FG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

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

Phase 1: Recommended Dose of Aflibercept for Phase 2

Recommended Dose was defined as the highest combination dose at which fewer than 33 percent (%) of participants experienced dose limiting toxicity during the first cycle of therapy.

Full analysis set (FAS) included all participants who were enrolled and received at least one dose of study drug. Data for this outcome measure has been reported for all participants in single arm.

Posted

Number

mg/kg

Phase 1: Baseline up to 315 Days

ID	Title	Description
OG000	Phase 1: All Participants	All participants who received intravenous infusion of aflibercept 2 mg/kg or 4 mg/kg or 6 mg/kg followed by pemetrexed 500 mg/square metere (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Units	Counts
Participants	OG00018

Title

Denominators

Categories

Title	Measurements
	OG0006

Secondary

Phase 2: Objective Response Rate

Objective response rate was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as assessed by modified Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the Baseline sum LD as reference.

FAS included all participants who were enrolled and received at least one dose of study drug.

Posted

Number

Percentage of Participants

Phase 2: Baseline (Day 421) up to end of study (Day 972)

ID	Title	Description
OG000	Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Phase 2: Progression-free Survival (PFS)

PFS was defined as the time in days from the date of first study drug administration to the date of first documentation of tumor progression or death from any cause, whichever occurs first, as assessed by the modified RECIST. Median time of PFS was estimated using Kaplan-Meier method.

FAS included all participants who were enrolled and received at least one dose of study drug.

Posted

Median

95% Confidence Interval

Days

Phase 2: Baseline (Day 421) up to end of study (Day 972)

ID	Title	Description
OG000	Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious AEs.

FAS included all participants who were enrolled and received at least one dose of study drug.

Posted

Count of Participants

Participants

Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin

Secondary

Phase 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Aflibercept

The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.

FAS included all participants who were enrolled and received at least one dose of study drug. Here "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

Day*milligrams per liter (mg/L)

Phase 1 and 2: Pre-dose up to Day 22 post-dose

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Secondary

Phase 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Pemetrexed

The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.

Posted

Mean

Standard Deviation

Hour*milligrams per liter (mg/L)

Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Secondary

Phase 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Aflibercept and Pemetrexed

Cmax is the maximum observed plasma concentration obtained directly from the concentration versus time curve.

FAS included all participants who were enrolled and received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable for specific category.

Posted

Mean

Standard Deviation

mg/L

Phase 1 and 2: Aflibercept: Pre-dose up to Day 22 post-dose; Pemetrexed: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Secondary

Phase 1 and 2: Total Body Clearance of Aflibercept

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Posted

Mean

Standard Deviation

Liter/Day/kg

Phase 1 and 2: Pre-dose up to Day 22 post-dose

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG002

Secondary

Phase 1 and 2: Total Body Clearance of Pemetrexed

Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Posted

Mean

Standard Deviation

Liter/hour/m^2

Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG002

Secondary

Phase 1 and 2: Terminal Half-Life (t1/2) of Aflibercept

Terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.

Posted

Mean

Standard Deviation

Days

Phase 1 and 2: Pre-dose up to Day 22 post-dose

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG002

Secondary

Phase 1 and 2: Terminal Half-Life (t1/2) of Pemetrexed

Terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.

Posted

Mean

Standard Deviation

Hours

Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Secondary

Phase 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) of Aflibercept

Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of ADA.

FAS included all participants who were enrolled and received at least one dose of study drug.

Posted

Count of Participants

Participants

Phase 1: Baseline up to 315 Days; Phase 2: Baseline (Day 421) up to Day 739

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG002	Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin

Secondary

Phase 1 and 2: Number of Participants With All Grade Glucose Abnormalities

FAS included all participants who were enrolled and received at least one dose of study drug.

Posted

Number

Participants

Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG002	Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Secondary

Phase 1 and 2: Number of Participants With All Grade Hematology Abnormalities

FAS included all participants who were enrolled and received at least one dose of study drug.

Posted

Number

Participants

Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days

ID	Title	Description
OG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
OG002	Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CHOLANGITIS	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG0030 events0 affected42 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected7 at risk EG0020 events0 affected7 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYDROPNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
FATIGUE	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
DISEASE PROGRESSION	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
CHEST PAIN	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
METASTATIC PAIN	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0021 events1 affected7 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
GINGIVAL INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
PNEUMOCOCCAL SEPSIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
METASTATIC PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
SPEECH DISORDER	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NAUSEA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events4 affected4 at risk EG0016 events5 affected7 at risk EG00211 events6 affected7 at risk EG00342 events28 affected42 at risk
VOMITING	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected4 at risk EG0014 events4 affected7 at risk EG0026 events4 affected7 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events3 affected4 at risk EG0014 events3 affected7 at risk EG00210 events6 affected7 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected4 at risk EG0014 events2 affected7 at risk EG0027 events4 affected7 at risk EG003
STOMATITIS	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected4 at risk EG0014 events3 affected7 at risk EG0026 events1 affected7 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0014 events3 affected7 at risk EG0021 events1 affected7 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected4 at risk EG0012 events2 affected7 at risk EG0021 events1 affected7 at risk EG003
ODYNOPHAGIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0012 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
ORAL PAIN	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
ASCITES	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
OESOPHAGEAL VARICES HAEMORRHAGE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected7 at risk EG0020 events0 affected7 at risk EG003
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0022 events2 affected7 at risk EG003
GINGIVAL PAIN	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
TOOTHACHE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
RETCHING	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
OROPHARYNGEAL PAIN	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
FATIGUE	General disorders	MedDRA (11.1)	Systematic Assessment	EG00012 events4 affected4 at risk EG00112 events6 affected7 at risk EG00229 events6 affected7 at risk EG003
FEELING ABNORMAL	General disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
PYREXIA	General disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
MUCOSAL INFLAMMATION	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
XEROSIS	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
INFUSION SITE WARMTH	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
LOCALISED OEDEMA	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
TEMPERATURE INTOLERANCE	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
CHEST PAIN	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0015 events3 affected7 at risk EG0028 events3 affected7 at risk EG003
GAIT DISTURBANCE	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
INJECTION SITE REACTION	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
CHILLS	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
CHEST DISCOMFORT	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
ASTHENIA	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
PAIN	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
CYST	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
OEDEMA	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
DYSGEUSIA	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected4 at risk EG0011 events1 affected7 at risk EG0024 events4 affected7 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events3 affected4 at risk EG0011 events1 affected7 at risk EG0028 events4 affected7 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0014 events2 affected7 at risk EG0024 events4 affected7 at risk EG003
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0013 events2 affected7 at risk EG0021 events1 affected7 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0024 events2 affected7 at risk EG003
TREMOR	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0023 events2 affected7 at risk EG003
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
HYPERSOMNIA	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected7 at risk EG0021 events1 affected7 at risk EG003
SINUS HEADACHE	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
CLONUS	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0023 events1 affected7 at risk EG003
INSOMNIA	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
ANOREXIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected4 at risk EG0019 events4 affected7 at risk EG00212 events5 affected7 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected4 at risk EG0012 events2 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPERNATRAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0022 events2 affected7 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0021 events1 affected7 at risk EG003
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0014 events1 affected7 at risk EG0021 events1 affected7 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
GOUT	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
WEIGHT LOSS POOR	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected4 at risk EG0013 events3 affected7 at risk EG0024 events4 affected7 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected4 at risk EG0015 events3 affected7 at risk EG0023 events3 affected7 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected4 at risk EG0014 events2 affected7 at risk EG0022 events2 affected7 at risk EG003
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected4 at risk EG0014 events2 affected7 at risk EG0021 events1 affected7 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected4 at risk EG0011 events1 affected7 at risk EG0025 events5 affected7 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0023 events3 affected7 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
RESPIRATORY DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0021 events1 affected7 at risk EG003
HYPOVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
NASAL DRYNESS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
NASAL ULCER	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
RHONCHI	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events2 affected4 at risk EG0013 events3 affected7 at risk EG0028 events5 affected7 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0012 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
HAEMATOMA	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
HOT FLUSH	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0024 events1 affected7 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
MUSCLE TWITCHING	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected7 at risk EG0024 events3 affected7 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected7 at risk EG0022 events2 affected7 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected7 at risk EG0027 events2 affected7 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0021 events1 affected7 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0021 events1 affected7 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0024 events3 affected7 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0023 events1 affected7 at risk EG003
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
SKIN INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0022 events1 affected7 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
ORAL HERPES	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
HERPES SIMPLEX	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
HERPES VIRUS INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
RHINITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
RASH PUSTULAR	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
SINUSITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HYPERKERATOSIS	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
SKIN ODOUR ABNORMAL	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0021 events1 affected7 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
SWELLING FACE	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events1 affected7 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
BLISTER	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
HAIR TEXTURE ABNORMAL	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
PAIN OF SKIN	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
VISION BLURRED	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected7 at risk EG0023 events2 affected7 at risk EG003
EYE IRRITATION	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
PHOTOPHOBIA	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
DRY EYE	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
VISUAL IMPAIRMENT	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
MYODESOPSIA	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
ANAEMIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected4 at risk EG0012 events2 affected7 at risk EG0020 events0 affected7 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
TINNITUS	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0024 events2 affected7 at risk EG003
DEAFNESS	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
EAR PAIN	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
AURICULAR SWELLING	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
EAR CANAL STENOSIS	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
HYPOACUSIS	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
CREATININE RENAL CLEARANCE DECREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
HEART RATE DECREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0015 events2 affected7 at risk EG00212 events4 affected7 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0025 events1 affected7 at risk EG003
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0023 events1 affected7 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0026 events1 affected7 at risk EG003
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events1 affected7 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
BLADDER DISCOMFORT	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
DYSURIA	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
PROTEINURIA	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
BRADYCARDIA	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
AMENORRHOEA	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected7 at risk EG0020 events0 affected7 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0023 events3 affected7 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0022 events2 affected7 at risk EG003
ABNORMAL DREAMS	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
HALLUCINATION	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
LOSS OF LIBIDO	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0020 events0 affected7 at risk EG003
SCRATCH	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected7 at risk EG0020 events0 affected7 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
OPEN WOUND	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected4 at risk EG0010 events0 affected7 at risk EG0021 events1 affected7 at risk EG003

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

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

ID	Term
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
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Title	Description
BG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
BG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
BG002	Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.
BG003	Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.	0	4	1	4	4	4
EG001	Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.	1	7	5	7	7	7
EG002	Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met.	1	7	3	7	7	7
EG003	Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin	Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.	5	42	16	42	41	42