A Study of Necitumumab and Chemotherapy in Participants W... | NCT01769391

ID	Type	Description	Link
I4X-MC-JFCL	Other Identifier	Eli Lilly and Company
2012-003214-13	EudraCT Number

Label	Type	Description	Intervention Names
Necitumumab +Paclitaxel+Carboplatin	Experimental	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.	Drug: Necitumumab Drug: Paclitaxel Drug: Carboplatin
Paclitaxel + Carboplatin	Active Comparator	Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.	Drug: Paclitaxel Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Necitumumab	Drug	Administered IV	Necitumumab +Paclitaxel+Carboplatin

Measure	Description	Time Frame
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])	The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	Baseline to Disease Progression or Death (Up to 24 Months)

Measure	Description	Time Frame
Overall Survival (OS)	OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).	Randomization to Date of Death (Up to 24 Months)

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Jonesboro	Arkansas	72401

ID	Title	Description
FG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
FG001

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

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])

The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

All randomized participants that received at least 1 dose of study drug, who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Disease Progression or Death (Up to 24 Months)

ID	Title	Description
OG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
OG001	Paclitaxel + Carboplatin	Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.

Units	Counts
Participants	OG00094 OG00150

Title

Denominators

Categories

Title	Measurements
	OG00048.9(38.5 to 59.5) OG00140.0(26.4 to 54.8)

Secondary

Overall Survival (OS)

OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).

All randomized participants; (49 and 19 censored participants in Paclitaxel + Carboplatin + Necitumumab and Paclitaxel + Carboplatin Arms, respectively.

Posted

Median

95% Confidence Interval

months

Randomization to Date of Death (Up to 24 Months)

ID	Title	Description
OG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
OG001	Paclitaxel + Carboplatin	Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.

Units

Secondary

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab

All participants who received at least one dose of necitumumab and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter (μg/mL)

Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)

ID	Title	Description
OG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Anti Necitumumab Antibodies

All participants who received any amount of necitumumab and had post baseline antibody data.

Posted

Number

percentage of participants

Baseline to End of Cycle 6

ID	Title	Description
OG000	Necitumumab + Paclitaxel+ Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

Units	Counts
Participants	OG000106

Secondary

Progression-Free Survival

Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.

All randomized participants; with 15 and 7 censored participants in Paclitaxel +Carboplatin + Necitumumab and Paclitaxel +Carboplatin Arms, respectively.

Posted

Median

95% Confidence Interval

months

Randomization to Progressive Disease or Death (Up to 24 Months)

ID	Title	Description
OG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
OG001	Paclitaxel + Carboplatin

Secondary

Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).

All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)

ID	Title	Description
OG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
OG001	Paclitaxel + Carboplatin	Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

Secondary

Percent Change in Tumor Size (CTS)

CTS is defined as maximum percent change from baseline in the sum of target lesions.

All randomized participants who received at least 1 dose of study drug and who had a decrease from baseline in the sum of target lesions.

Posted

Mean

Standard Deviation

percent change in tumor size

Baseline to Progressive Disease or Death (Up to 24 Months)

ID	Title	Description
OG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
OG001	Paclitaxel + Carboplatin	Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

All participants who received at least one dose of study drug and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram/milliliter (ng/mL)

Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)

ID	Title	Description
OG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected106 at risk EG0014 events4 affected55 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0007 events7 affected106 at risk EG0013 events2 affected55 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected55 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected106 at risk EG0012 events2 affected55 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0003 events2 affected106 at risk EG0011 events1 affected55 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected106 at risk EG0014 events4 affected55 at risk
Cardiac arrest	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Myocardial infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected55 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Ileus	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events1 affected106 at risk EG0010 events0 affected55 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Asthenia	General disorders	MedDRA 16.0	Systematic Assessment	EG00010 events5 affected106 at risk EG0010 events0 affected55 at risk
Brain death	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Death	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Mucosal inflammation	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Non-cardiac chest pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Oedema peripheral	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0011 events1 affected55 at risk
Sudden death	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Bacterial sepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Cellulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected55 at risk
Diverticulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Herpes simplex	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Herpes zoster	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Lung infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Perirectal abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00015 events14 affected106 at risk EG0014 events4 affected55 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Pneumonia viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Sepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0004 events3 affected106 at risk EG0012 events2 affected55 at risk
Septic shock	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected55 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Neutrophil count decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0012 events1 affected55 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Encephalopathy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Loss of consciousness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Syncope	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected55 at risk
Delirium	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Mental status changes	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0011 events1 affected55 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected55 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected55 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0011 events1 affected55 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected106 at risk EG0011 events1 affected55 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected55 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected55 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected55 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected55 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events1 affected55 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Circulatory collapse	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected55 at risk
Haemorrhage	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected55 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG00087 events34 affected106 at risk EG00162 events27 affected55 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG00016 events9 affected106 at risk EG00115 events9 affected55 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG00073 events37 affected106 at risk EG00143 events16 affected55 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG00067 events27 affected106 at risk EG00131 events14 affected55 at risk
Vision blurred	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0013 events3 affected55 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00011 events8 affected106 at risk EG0012 events2 affected55 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00028 events25 affected106 at risk EG00123 events15 affected55 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00034 events26 affected106 at risk EG00118 events12 affected55 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected106 at risk EG0013 events3 affected55 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00035 events27 affected106 at risk EG00134 events20 affected55 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00015 events14 affected106 at risk EG0013 events3 affected55 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00017 events13 affected106 at risk EG00111 events8 affected55 at risk
Asthenia	General disorders	MedDRA 16.0	Systematic Assessment	EG00031 events18 affected106 at risk EG0015 events3 affected55 at risk
Fatigue	General disorders	MedDRA 16.0	Systematic Assessment	EG00052 events33 affected106 at risk EG00148 events24 affected55 at risk
Non-cardiac chest pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0008 events7 affected106 at risk EG0011 events1 affected55 at risk
Oedema peripheral	General disorders	MedDRA 16.0	Systematic Assessment	EG00015 events11 affected106 at risk EG0019 events7 affected55 at risk
Pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0009 events7 affected106 at risk EG0010 events0 affected55 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG00016 events10 affected106 at risk EG0015 events4 affected55 at risk
Conjunctivitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0009 events7 affected106 at risk EG0010 events0 affected55 at risk
Paronychia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0009 events6 affected106 at risk EG0010 events0 affected55 at risk
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0009 events6 affected106 at risk EG0012 events2 affected55 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0014 events3 affected55 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0009 events7 affected106 at risk EG0010 events0 affected55 at risk
Neutrophil count decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG00018 events8 affected106 at risk EG0017 events6 affected55 at risk
Weight decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG00049 events31 affected106 at risk EG00120 events14 affected55 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00040 events34 affected106 at risk EG00120 events15 affected55 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00015 events11 affected106 at risk EG00117 events10 affected55 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0009 events5 affected106 at risk EG0014 events3 affected55 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00019 events10 affected106 at risk EG0012 events2 affected55 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00028 events14 affected106 at risk EG0017 events4 affected55 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00074 events25 affected106 at risk EG00112 events7 affected55 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00013 events7 affected106 at risk EG0011 events1 affected55 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00061 events24 affected106 at risk EG00129 events13 affected55 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00011 events10 affected106 at risk EG0013 events3 affected55 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00010 events8 affected106 at risk EG00114 events8 affected55 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00010 events10 affected106 at risk EG0017 events4 affected55 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0019 events7 affected55 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0005 events3 affected106 at risk EG0017 events4 affected55 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00044 events18 affected106 at risk EG00121 events12 affected55 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00010 events8 affected106 at risk EG0018 events8 affected55 at risk
Dizziness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00016 events14 affected106 at risk EG00110 events8 affected55 at risk
Dysgeusia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00010 events8 affected106 at risk EG0014 events4 affected55 at risk
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0006 events4 affected106 at risk EG0017 events7 affected55 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00021 events13 affected106 at risk EG00118 events9 affected55 at risk
Paraesthesia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0013 events3 affected55 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00054 events31 affected106 at risk EG00124 events13 affected55 at risk
Syncope	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0008 events8 affected106 at risk EG0011 events1 affected55 at risk
Anxiety	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected106 at risk EG0010 events0 affected55 at risk
Insomnia	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG00016 events14 affected106 at risk EG0017 events6 affected55 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG00024 events18 affected106 at risk EG00110 events10 affected55 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0005 events4 affected106 at risk EG0014 events3 affected55 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG00029 events23 affected106 at risk EG00113 events6 affected55 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0014 events3 affected55 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0013 events3 affected55 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0007 events7 affected106 at risk EG0018 events6 affected55 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 events4 affected106 at risk EG0013 events3 affected55 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0013 events3 affected55 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0014 events3 affected55 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00030 events28 affected106 at risk EG00111 events10 affected55 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00040 events23 affected106 at risk EG0010 events0 affected55 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00013 events13 affected106 at risk EG0011 events1 affected55 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected106 at risk EG0010 events0 affected55 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00069 events22 affected106 at risk EG0011 events1 affected55 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00017 events8 affected106 at risk EG0010 events0 affected55 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00016 events12 affected106 at risk EG0010 events0 affected55 at risk
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG00013 events12 affected106 at risk EG00110 events7 affected55 at risk

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

ID	Title	Description
BG000	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
BG001	Paclitaxel + Carboplatin	Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue 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	Necitumumab +Paclitaxel+Carboplatin	Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles.			43	106	102	106
EG001	Paclitaxel + Carboplatin	Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.			21	55	49	55