A Study of Emibetuzumab in Non Small Cell Lung Cancer (NS... | NCT01900652

ID	Type	Description	Link
I4C-MC-JTBC	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Arm A: Emibetuzumab plus Erlotinib	Experimental	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.	Drug: Emibetuzumab Drug: Erlotinib
Arm B: Emibetuzumab	Experimental	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.	Drug: Emibetuzumab

Name	Type	Description	Arm Group Labels	Other Names
Emibetuzumab	Drug	Administered IV	Arm A: Emibetuzumab plus Erlotinib Arm B: Emibetuzumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])	ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.	Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.

Eligibility Module

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
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
University of California - San Diego

ID	Title	Description
FG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
FG001	Arm B: Emibetuzumab 750mg

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 Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.

All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
OG002	MET-High Analysis Population (Emibetuzumab + Erlotinib)	Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
OG003	MET-High Analysis Population (Emibetuzumab)	Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.

Units	Counts
Participants	OG00066 OG00123 OG00253 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003.0(0.4 to 10.5) OG0014.3(0.1 to 21.9) OG0023.8(0.5 to 13.0) OG003

Secondary

Progression Free Survival (PFS)

PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.

Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.

All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Secondary

Time to Progressive Disease

All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.

Posted

Median

95% Confidence Interval

months

Baseline to Objective Disease Progression (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Units	Counts
Participants	OG000

Secondary

Change in Tumor Size (CTS)

Zero participants analyzed. CTS data was not collected for analysis due to N=0 CR and N=3 PR.

Zero participants analyzed.CTS data was not collected for analysis due to N=0 CR and N=3 PR.

Posted

Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: LY2875358	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Units	Counts
Participants	OG000

Secondary

Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]

Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.

All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001

Secondary

Duration of Response (DoR)

Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.

Posted

Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.

All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.

Posted

Median

95% Confidence Interval

Months

Baseline to Death Due to Any Cause (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Units	Counts
Participants

Secondary

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)

EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.

All randomized participants with EORTC QLQ-C30 values at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Secondary

Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)

The EORTC lung module QLQ-LC13 comprises 13 items consisting of one multi-item scale to assess dyspnea and a series of single-item measures assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. The higher scores represent a greater degree of symptoms.

All randomized participants with EORTC QLQ-LC13 values at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
OG002	MET-High Analysis Population	Participants with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.

Secondary

Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)

The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.

Additionally, participants will indicate their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).

All randomized participants with EQ-5D values at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Secondary

Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab

AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.

All participants who received Emibetuzumab on Cycle 1, Day 1, and contributed samples for analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram*hour/milliliter (ug*hr/mL)

Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion

ID	Title	Description
OG000	Emibetuzumab	All participants who received Emibetuzumab on Cycle 1, Day 1, and contributed samples for analysis.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response

All participants who received at least one dose of study drug and have sufficient Anti-Emibetuzumab Antibody sample for the analysis.

Posted

Number

participants

Baseline through 30-Day Follow-Up (Up to 24 Months)

ID	Title	Description
OG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
OG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pericardial effusion	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Hypothyroidism	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Ascites	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected83 at risk EG0010 events0 affected28 at risk
Chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected28 at risk
General physical health deterioration	General disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected83 at risk EG0010 events0 affected28 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected28 at risk
Pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected28 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected28 at risk
Rash pustular	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0012 events1 affected28 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected28 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Tracheobronchitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected28 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected28 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected28 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected28 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected28 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Seizure	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0005 events4 affected83 at risk EG0011 events1 affected28 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected28 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0006 events5 affected83 at risk EG0012 events1 affected28 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0006 events6 affected83 at risk EG0013 events2 affected28 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected28 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected28 at risk
Embolism	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected28 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG00016 events11 affected83 at risk EG0013 events3 affected28 at risk
Tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0012 events2 affected28 at risk
Lacrimation increased	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected28 at risk
Vision blurred	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0012 events2 affected28 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected83 at risk EG0015 events3 affected28 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00021 events18 affected83 at risk EG0018 events8 affected28 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00036 events21 affected83 at risk EG0019 events7 affected28 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0006 events4 affected83 at risk EG0012 events2 affected28 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00032 events27 affected83 at risk EG0017 events7 affected28 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00011 events9 affected83 at risk EG0012 events2 affected28 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00024 events16 affected83 at risk EG0018 events6 affected28 at risk
Asthenia	General disorders	MedDRA 18.1	Systematic Assessment	EG00019 events9 affected83 at risk EG0015 events5 affected28 at risk
Axillary pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0013 events3 affected28 at risk
Chills	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected83 at risk EG0012 events2 affected28 at risk
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG00059 events40 affected83 at risk EG00115 events11 affected28 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected83 at risk EG0012 events2 affected28 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG00042 events30 affected83 at risk EG00115 events9 affected28 at risk
Pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0013 events2 affected28 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0005 events4 affected83 at risk EG0014 events4 affected28 at risk
Paronychia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00018 events11 affected83 at risk EG0010 events0 affected28 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00010 events6 affected83 at risk EG0011 events1 affected28 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected83 at risk EG0012 events2 affected28 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected83 at risk EG0012 events2 affected28 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0008 events6 affected83 at risk EG0012 events2 affected28 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0007 events6 affected83 at risk EG0011 events1 affected28 at risk
Prothrombin time prolonged	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected28 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG00027 events25 affected83 at risk EG0014 events4 affected28 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG00025 events13 affected83 at risk EG0010 events0 affected28 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected83 at risk EG0010 events0 affected28 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00013 events8 affected83 at risk EG0010 events0 affected28 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0008 events8 affected83 at risk EG0013 events1 affected28 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected83 at risk EG0012 events2 affected28 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected83 at risk EG0010 events0 affected28 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events1 affected83 at risk EG0013 events3 affected28 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected83 at risk EG0015 events3 affected28 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0009 events7 affected83 at risk EG0011 events1 affected28 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00010 events7 affected83 at risk EG0014 events4 affected28 at risk
Dizziness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected83 at risk EG0011 events1 affected28 at risk
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected83 at risk EG0014 events3 affected28 at risk
Anxiety	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0013 events2 affected28 at risk
Insomnia	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected83 at risk EG0010 events0 affected28 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected28 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00021 events17 affected83 at risk EG0018 events8 affected28 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00030 events22 affected83 at risk EG00111 events8 affected28 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected83 at risk EG0013 events2 affected28 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0008 events4 affected83 at risk EG0013 events3 affected28 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected83 at risk EG0010 events0 affected28 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0006 events5 affected83 at risk EG0012 events2 affected28 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0012 events2 affected28 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG00023 events15 affected83 at risk EG0012 events2 affected28 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0008 events8 affected83 at risk EG0012 events2 affected28 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected83 at risk EG0012 events2 affected28 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected83 at risk EG0012 events2 affected28 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG00024 events9 affected83 at risk EG0010 events0 affected28 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0008 events6 affected83 at risk EG0010 events0 affected28 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected83 at risk EG0014 events4 affected28 at risk

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

ID	Term
C000599789	emibetuzumab
D000069347	Erlotinib Hydrochloride

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab (LY2875358) flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
BG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
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	Arm A: Emibetuzumab Plus Erlotinib	750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.	0	83	36	83	82	83
EG001	Arm B: Emibetuzumab	750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.	0	28	11	28	28	28