Carboplatin And Paclitaxel With Or Without CP-751, 871 (A... | NCT00596830

Label	Type	Description	Intervention Names
A	Experimental	Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'	Drug: CP-751,871 (Figitumumab) Drug: Carboplatin Drug: Paclitaxel
B	Active Comparator	Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.	Drug: Carboplatin Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
CP-751,871 (Figitumumab)	Drug	CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.	Baseline until death, assessed monthly after end of treatment, up to 30 months

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Florence	Alabama	35630	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
41332393	Derived	Roeland EJ, Fintelmann FJ, Yang R, Tarasenko L, Bonomi PD. Evaluation of Weight Gain and Overall Survival of Men Versus Women With Advanced Non-Small Cell Lung Cancer. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70131. doi: 10.1002/jcsm.70131.
38468440	Derived	Roeland EJ, Fintelmann FJ, Hilton F, Yang R, Whalen E, Tarasenko L, Calle RA, Bonomi PD. The relationship between weight gain during chemotherapy and outcomes in patients with advanced non-small cell lung cancer. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1030-1040. doi: 10.1002/jcsm.13426. Epub 2024 Mar 11.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.

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

Overall Survival (OS)

Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.

All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

Posted

Median

95% Confidence Interval

months

Baseline until death, assessed monthly after end of treatment, up to 30 months

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.

Units	Counts
Participants	OG000342 OG001339

Title

Denominators

Categories

Title	Measurements
	OG0008.6(7.4 to 9.3) OG0019.8(8.6 to 10.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.064	The p-value stated is the 2-sided p-value from the log rank test stratified by gender, prior adjuvant chemotherapy, and histology.	Hazard Ratio (HR)	1.179			2-Sided	95	0.990	1.404				No	Superiority or Other

Secondary

Progression-Free Survival (PFS)

PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).

All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

Posted

Median

95% Confidence Interval

months

At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)

Secondary

Percentage of Participants With Objective Response (OR)

Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.

All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

Posted

Number

95% Confidence Interval

percentage of participants

At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)

Secondary

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.

Due to futility, the study was terminated early; therefore these data were not analyzed.

Posted

Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)

Secondary

European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score

QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

Due to futility, the study was terminated early; therefore these data were not analyzed.

Posted

Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)

Secondary

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state.

Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.

Posted

Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)

Secondary

Maximum Observed Plasma Concentration (Cmax) for Figitumumab

This study was terminated early due to futility. As such, Cmax was not summarized.

Posted

Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.

Units	Counts
Participants	OG000

Secondary

Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab

This study was terminated early due to futility. As such, Cmin was not summarized.

Posted

Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.

Units	Counts

Secondary

Number of Participants With Total Anti-drug Antibodies (ADA)

ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.

All participants who received figitumumab (CP-751,871).

Posted

Number

participants

Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.

Secondary

Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels

This study was terminated early due to futility. As such, these data were not analyzed.

Posted

Cycles 1 and 4 (predose) and at end of treatment

ID	Title	Description
OG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
OG001	Paclitaxel and Carboplatin (Chemo)	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0019 affected333 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0005 affected338 at risk EG00111 affected333 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0012 affected333 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0005 affected338 at risk EG0011 affected333 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0015 affected333 at risk
Angina pectoris	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Arrhythmia	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Cardiac arrest	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Cardiac failure	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0011 affected333 at risk
Cardiotoxicity	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Myocardial infarction	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0012 affected333 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Vertigo	Ear and labyrinth disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Anal fistula	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0009 affected338 at risk EG0010 affected333 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0011 affected333 at risk
Glossitis	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Haematemesis	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Nausea	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0012 affected333 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Vomiting	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0007 affected338 at risk EG0011 affected333 at risk
Adverse drug reaction	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Asthenia	General disorders	MedDRA v14.0	Non-systematic Assessment	EG00011 affected338 at risk EG0012 affected333 at risk
Chest pain	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0010 affected333 at risk
Condition aggravated	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Death	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0013 affected333 at risk
Disease progression	General disorders	MedDRA v14.0	Non-systematic Assessment	EG000115 affected338 at risk EG00190 affected333 at risk
Drug intolerance	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0012 affected333 at risk
Fatigue	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0012 affected333 at risk
General physical health deterioration	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0008 affected338 at risk EG0015 affected333 at risk
Malaise	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Multi-organ failure	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Pain	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0013 affected333 at risk
Performance status decreased	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0012 affected333 at risk
Pyrexia	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0004 affected338 at risk EG0014 affected333 at risk
Sudden death	General disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Anal abscess	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Bone abscess	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Bronchitis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Candidiasis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Cellulitis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Diverticulitis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Erysipelas	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Gastroenteritis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Infection	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Lung abscess	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Lung infection	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Neutropenic sepsis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Oral candidiasis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Pneumonia	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG00021 affected338 at risk EG00112 affected333 at risk
Pseudomonas infection	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Pyothorax	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Respiratory tract infection	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Sepsis	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0004 affected338 at risk EG0010 affected333 at risk
Septic shock	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0011 affected333 at risk
Sputum purulent	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Staphylococcal infection	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Urinary tract infection	Infections and infestations	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0012 affected333 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0010 affected333 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Blood creatinine increased	Investigations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Blood glucose increased	Investigations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
General physical condition abnormal	Investigations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Haemoglobin decreased	Investigations	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0012 affected333 at risk
Platelet count decreased	Investigations	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Weight decreased	Investigations	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0005 affected338 at risk EG0010 affected333 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG00015 affected338 at risk EG0012 affected333 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0012 affected333 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG00011 affected338 at risk EG0011 affected333 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0011 affected333 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Genitourinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0010 affected333 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0013 affected333 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Cerebral infarction	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0013 affected333 at risk
Convulsion	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Dizziness	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Hemiparesis	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Hydrocephalus	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Lethargy	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0012 affected333 at risk
Neurotoxicity	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Spinal cord compression	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Syncope	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0011 affected333 at risk
Tremor	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Completed suicide	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Confusional state	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0010 affected333 at risk
Delirium	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Depression	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Hallucination	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Insomnia	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Mental status changes	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Haematuria	Renal and urinary disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Renal colic	Renal and urinary disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Renal failure	Renal and urinary disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0012 affected333 at risk
Renal failure acute	Renal and urinary disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0011 affected333 at risk
Renal impairment	Renal and urinary disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Urinary retention	Renal and urinary disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0011 affected333 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0011 affected333 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0006 affected338 at risk EG0016 affected333 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0009 affected338 at risk EG0015 affected333 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Mediastinal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0012 affected333 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0011 affected333 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0007 affected338 at risk EG0016 affected333 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0011 affected333 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0012 affected333 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Arteritis	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0012 affected333 at risk
Haemorrhage	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0002 affected338 at risk EG0010 affected333 at risk
Hypotension	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0003 affected338 at risk EG0010 affected333 at risk
Hypovolaemic shock	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Orthostatic hypotension	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0000 affected338 at risk EG0011 affected333 at risk
Thrombosis	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0011 affected333 at risk
Vena cava thrombosis	Vascular disorders	MedDRA v14.0	Non-systematic Assessment	EG0001 affected338 at risk EG0010 affected333 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG00093 affected338 at risk EG00185 affected333 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG00018 affected338 at risk EG00133 affected333 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG00074 affected338 at risk EG00178 affected333 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v14.0	Non-systematic Assessment	EG00060 affected338 at risk EG00149 affected333 at risk
Constipation	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00060 affected338 at risk EG00161 affected333 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00095 affected338 at risk EG00145 affected333 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00018 affected338 at risk EG0019 affected333 at risk
Nausea	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG000132 affected338 at risk EG001101 affected333 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00030 affected338 at risk EG00110 affected333 at risk
Vomiting	Gastrointestinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00082 affected338 at risk EG00146 affected333 at risk
Asthenia	General disorders	MedDRA v14.0	Non-systematic Assessment	EG00071 affected338 at risk EG00159 affected333 at risk
Chest pain	General disorders	MedDRA v14.0	Non-systematic Assessment	EG00045 affected338 at risk EG00134 affected333 at risk
Fatigue	General disorders	MedDRA v14.0	Non-systematic Assessment	EG000112 affected338 at risk EG00185 affected333 at risk
Mucosal inflammation	General disorders	MedDRA v14.0	Non-systematic Assessment	EG00027 affected338 at risk EG0019 affected333 at risk
Oedema peripheral	General disorders	MedDRA v14.0	Non-systematic Assessment	EG00010 affected338 at risk EG00124 affected333 at risk
Pyrexia	General disorders	MedDRA v14.0	Non-systematic Assessment	EG00026 affected338 at risk EG00133 affected333 at risk
Weight decreased	Investigations	MedDRA v14.0	Non-systematic Assessment	EG00065 affected338 at risk EG00129 affected333 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG000128 affected338 at risk EG00175 affected333 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG00028 affected338 at risk EG00110 affected333 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG00074 affected338 at risk EG00116 affected333 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v14.0	Non-systematic Assessment	EG00017 affected338 at risk EG0015 affected333 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG00047 affected338 at risk EG00157 affected333 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG00019 affected338 at risk EG00119 affected333 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG00019 affected338 at risk EG0015 affected333 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG00020 affected338 at risk EG00117 affected333 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG00039 affected338 at risk EG00144 affected333 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG00033 affected338 at risk EG00123 affected333 at risk
Dizziness	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG00037 affected338 at risk EG00132 affected333 at risk
Dysgeusia	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG00026 affected338 at risk EG00113 affected333 at risk
Headache	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG00037 affected338 at risk EG00122 affected333 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG00063 affected338 at risk EG00156 affected333 at risk
Paraesthesia	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG00029 affected338 at risk EG00135 affected333 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v14.0	Non-systematic Assessment	EG00040 affected338 at risk EG00150 affected333 at risk
Anxiety	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG00017 affected338 at risk EG00117 affected333 at risk
Insomnia	Psychiatric disorders	MedDRA v14.0	Non-systematic Assessment	EG00032 affected338 at risk EG00130 affected333 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00066 affected338 at risk EG00159 affected333 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00056 affected338 at risk EG00165 affected333 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00026 affected338 at risk EG0013 affected333 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v14.0	Non-systematic Assessment	EG00032 affected338 at risk EG00121 affected333 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG000138 affected338 at risk EG001146 affected333 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG00026 affected338 at risk EG00118 affected333 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v14.0	Non-systematic Assessment	EG00028 affected338 at risk EG00120 affected333 at risk

ID	Term
D002294	Carcinoma, Squamous Cell
D018196	Carcinoma, Adenosquamous
D018287	Carcinoma, Large Cell
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018307	Neoplasms, Squamous Cell
D018193	Neoplasms, Complex and Mixed
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
BG001	Paclitaxel and Carboplatin (Chemo)	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
BG002	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	Figitumumab + Paclitaxel and Carboplatin	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.			223	338	316	338
EG001	Paclitaxel and Carboplatin (Chemo)	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.			170	333	303	333